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Background: The development of artificial intelligence (AI) is rapidly expanding, showing promise in the dermatological field. Skin checks are a resource-heavy challenge that could potentially benefit from AI-tool assistance, particularly if provided in widely available AI solutions. A novel smartphone application(app)-based AI system, "SCAI," was developed and trained to recognize spots in paired images of skin, pursuing identification of new skin lesions. This pilot study aimed to investigate the feasibility of the SCAI-app to identify simulated skin changes in vivo., Materials and Methods: The study was conducted in a controlled setting with healthy volunteers and standardized, simulated skin changes (test spots), consisting of customized 3-mm adhesive spots in three colors (black, brown, and red). Each volunteer had a total of eight test spots adhered to four areas on back and legs. The SCAI-app collected smartphone- and template-guided standardized images before and after test spot application, using its backend AI algorithms to identify changes between the paired images., Results: Twenty-four volunteers were included, amounting to a total of 192 test spots. Overall, the detection algorithms identified test spots with a sensitivity of 92.0% (CI: 88.1-95.9) and a specificity of 95.5% (CI: 95.0-96.0). The SCAI-app's positive predictive value was 38.0% (CI: 31.0-44.9), while the negative predictive value was 99.7% (CI: 99.0-100)., Conclusion: This pilot study showed that SCAI-app could detect simulated skin changes in a controlled in vivo setting. The app's feasibility in a clinical setting with real-life skin lesions remains to be investigated, where the challenge with false positives in particular needs to be addressed., (© 2024 The Author(s). Skin Research and Technology published by John Wiley & Sons Ltd.)

Botulinum toxin A (BTX) and microwave thermolysis (MWT) are standard axillary hyperhidrosis treatments, but comparison of their subclinical effects is lacking. Line-field confocal optical coherence tomography (LC-OCT) is a promising non-invasive imaging tool for visualizing tissue-interactions. This study aimed to describe subclinical effects of BTX and MWT for axillary hyperhidrosis with LC-OCT-imaging compared to histology. This study derived from an intra-individual, randomized, controlled trial, treating axillary hyperhidrosis with BTX versus MWT. Subclinical effects based on LC-OCT images from baseline and 6-month follow-up (n = 8 patients) were evaluated and compared to corresponding histological samples. At baseline, LC-OCT visualized eccrine pores at the skin surface and ducts in the upper dermis (500 μm), but not deeper-lying sweat glands. Histology identified entire sweat glands. Six months post-treatment, LC-OCT revealed no detectable morphology changes in any BTX-treated axillae (100%), while recognizing obstructed eccrine pores and atrophy of eccrine ducts in most MWT-treated axillae (75%). Histology corroborated LC-OCT findings, while also showing substantial changes to entire sweat glands. LC-OCT enabled visualization of subclinical alterations of superficial eccrine ducts after MWT and unchanged morphology after BTX. LC-OCT is a promising tool for non-invasive assessment of treatment-specific tissue-interactions that can be complementary to histology., (© 2024 The Author(s). Experimental Dermatology published by John Wiley & Sons Ltd.)

Background: Botulinum toxin A (BTX) and microwave thermolysis (MWT) represent 2 treatment modalities for axillary hyperhidrosis with different procedural and efficacy profiles., Objective: To compare long-term outcomes following BTX vs MWT treatment of axillary hyperhidrosis., Methods: A prospective, randomized, within-patient, controlled trial, treating axillary hyperhidrosis with contralateral BTX and MWT. Objective sweat measurement and patient-reported outcome measures for sweat and odor were collected at baseline, 6-month and 1-year follow-up (6M/1YFU). Hair reduction and patient treatment preference was also assessed., Results: Sweat reduction was significant (all P <.01) for both interventions throughout the study. Objectively, sweat reduction was equal at 1-year FU (Δ P =.4282), but greater for BTX than MWT at 6-month FU (Δ P =.0053). Subjective sweat assessment presented comparable efficacy (6MFU: Δ P =.4142, 1YFU: Δ P =.1025). Odor reduction was significant (all P <.01) following both interventions, whereas only sustaining for MWT (6MFU: Δ P =.6826, 1YFU: Δ P =.0098). Long-term, hair reduction was visible after MWT, but not BTX (Δ P ≤.0001), and MWT was preferred by the majority of patients (76%)., Limitations: The intrinsic challenges in efficacy assessment., Conclusion: This study exhibited BTX and MWT with similar sweat reduction, but distinguishable odor and hair reduction at 1-year FU. These findings support individualized treatment approaches for axillary hyperhidrosis based on patient-specific symptoms and preferences., Competing Interests: Dr Haedersdal has received speaker honorarium for microwave thermolysis symposium. Drs Grove, Togsverd-Bo, and Zachariae have no conflicts of interest to declare., (© 2024 by the American Academy of Dermatology, Inc. Published by Elsevier Inc.)

Background: Atrial fibrillation (AF) is the most common arrythmia following ST-segment elevation myocardial infarction (STEMI) and can lead to stroke and other heart-related diseases. This study aimed to determine the prognostic value of left atrial (LA) strain, obtained by speckle tracking echocardiography (STE), in predicting incident AF outcomes following STEMI treated with primary percutaneous coronary intervention (pPCI)., Methods and Results: This prospective study comprised of 392 STEMI patients treated with pPCI. The patients had an echocardiography performed at a median of two days after their STEMI. Along with conventional measures, LA strain was obtained by speckle tracking from two apical projections. The outcome was new-onset atrial fibrillation. LA reservoir, contractile and conduit strain were measurable from echocardiograms of 303 included patients. At a median follow-up time of 5.6 years (IQR: 5.0-6.1 years), 18 patients (6,3%) developed incident AF. Mean age was 62.0 years ±11.5 and follow-up was 100%. Significantly lower LA strain values were observed in patients who experienced AF during follow-up as compared to patients who didn't. Both reservoir, contractile and conduit strain were significant univariable predictors. In the multivariable model, only LA reservoir strain remained a significant independent predictor of AF., Conclusion: Left atrial reservoir strain obtained by two-dimensional speckle tracking echocardiography is an independent predictor of incident AF following STEMI., (Copyright © 2022 The Author(s). Published by Elsevier B.V. All rights reserved.)

Acute coronary syndrome (ACS) may lead to adverse remodelling and impaired cardiac function. Limited data exists on the effect of culprit coronary artery lesion site and impact on longitudinal cardiac remodelling. The present study included a total of 299 patients suffering from ACS treated with percutaneous coronary intervention (PCI). All patients had two echocardiographic examinations. The first echocardiography was median 2(IQR: 1;3) days following PCI, while the follow-up echocardiography (FUE) was median 257(IQR: 96;942) days following the first. Patients were grouped based on coronary artery PCI location; left anterior descending artery (LAD), right coronary artery (RCA) or circumflex artery (Cx). Patients with multiple lesions were excluded. Mean age was 63 ± 11 years and 77% were male. At FUE, mean left ventricular ejection fraction was 42 ± 9% and global longitudinal strain (GLS) was - 13 ± 4%. PCI treatment was allocated as 168 LAD lesions, 95 RCA lesions, and 36 Cx lesions. Linear regression analysis showed that patients with a LAD lesion displayed worsening in E/A (mean ∆ = 0.05, β = - 0.196, p = 0.001) and a larger increase in LVEDV (mean ∆ = 33.18 mL, β = 0.135, p = 0.012). Meanwhile patients with Cx lesion were significantly associated with a larger decrease in E/e' (mean ∆ = 2.6, β = - 0.120, p = 0.028). Patients with Cx lesion were observed to have elevated E/e' at baseline, which normalized at FUE. The present study suggests that culprit coronary artery lesion has a differential impact on myocardial remodelling. This information may potentially aid in understanding the pathophysiological differences in cardiac structure and function amongst patients with ACS., (© 2021. The Author(s), under exclusive licence to Springer Nature B.V.)

Global Longitudinal Strain (GLS) is a well-established predictor of heart failure (HF) following acute coronary syndrome (ACS). We aim to investigate the prognostic value of GLS obtained at a follow-up consultation, as well as the change in GLS for long-term risk of incident HF. A total of 235 ACS patients had an echocardiogram performed immediately after percutaneous coronary intervention (PCI) and a follow-up echocardiogram (FUE) median 215 (IQR: 71; 878) days after the first echocardiogram. Endpoint was incident HF. Follow-up time after FUE was median 4.8 (IQR: 3.7; 5.6) years. Patients diagnosed with HF before FUE were excluded. Mean age was 63 ± 11 years and 77% were male. Baseline GLS was on average 12.7 ± 3.9%, FUE GLS was on average 13.5 ± 3.9% and mean improvement in GLS was 0.73 ± 3.68% between the 2 echocardiograms. A total of 57 (24%) patients suffered incident HF following the FUE. FUE GLS provided significantly higher prognostic information for risk of incident HF than ∆GLS when assessed by the C-statistics (C-statistics: 0.71 vs. 0.61, P = 0.021). Furthermore, after multivariable adjustments only FUE GLS [HR = 1.15, 95% CI (1.02; 1.29), P = 0.018, per 1% decrease] remained an independent predictor of incident HF. In patients with ACS, who do not develop HF before FUE, FUE GLS was an independent predictor of long-term risk of incident HF while ∆GLS was not., (© 2021. The Author(s), under exclusive licence to Springer Nature B.V.)

The aim of this study was to evaluate layer-specific global longitudinal strain (GLS), obtained by speckle tracking, in predicting outcomes following ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (pPCI). Echocardiography, including layer-specific GLS, was performed at median two days after the STEMI in a prospective study of STEMI patients treated with pPCI between September 2006 and December 2008. The outcome was the composite of heart failure hospitalization and/or cardiovascular death (HF/CVD). A total of 349 patients were included. Mean age was 62.2 ± 11.5 years, 76% were male, and mean ejection fraction (LVEF) was 46 ± 9. Seventy-seven (22%) patients developed HF/CVD during median follow-up 5.4 years. Patients with HF/CVD had lower absolute values for all GLS-layers: endocardial (GLS Endo ) 11.4%vs 14.5% (p < 0.001), midmyocardial (GLS Mid ) 9.8% vs 12.5% (p < 0.001) and epicardial (GLS Epi ) 8.5% vs 10.9% (p < 0.001). In unadjusted analysis, all layers were significant predictors of HF/CVD; hazard ratio (HR) per 1% decrease for GLS Endo : HR 1.18 (95%CI 1.11-1.25), GLS Mid : HR 1.22 (95%CI 1.14-1.30) and GLS Epi : HR 1.26 (95%CI 1.16-1.36), p < 0.0001 for all. The risk of HF/CVD increased incrementally with increasing tertiles for all layers, being more than three times higher in 3rd tertile compared to 1st tertile. In multivariable models, including baseline clinical and echocardiographic parameters, only GLS Mid and GLS Epi remained independent predictors of HF/CVD. Global longitudinal strain obtained from all myocardial layers were significant predictors of incident HF and CVD following STEMI, however, only GLS Mid and GLS Epi remained independent predictors after multivariable adjustment., (© 2021. The Author(s), under exclusive licence to Springer Nature B.V.)

X-linked hypohidrotic ectodermal dysplasia (XLHED) is caused by defects in the EDA gene that inactivate the function of ectodysplasin A1 (EDA1). This leads to abnormal development of eccrine glands, hair follicles, and teeth, and to frequent respiratory infections. Previous studies in the naturally occurring dog model demonstrated partial prevention of the XLHED phenotype by postnatal administration of recombinant EDA1. The results suggested that a single or two temporally spaced injections of EDI200 prenatally might improve the clinical outcome in the dog model. Fetuses received ultrasound-guided EDI200 intra-amniotically at gestational days 32 and 45, or 45 or 55 alone (of a 65-day pregnancy). Growth rates, lacrimation, hair growth, meibomian glands, sweating, dentition, and mucociliary clearance were compared in treated and untreated XLHED-affected dogs, and in heterozygous and wild-type control dogs. Improved phenotypic outcomes were noted in the earlier and more frequently treated animals. All animals treated prenatally showed positive responses compared with untreated dogs with XLHED, most notably in the transfer of moisture through paw pads, suggesting improved onset of sweating ability and restored meibomian gland development. These results exemplify the feasibility of ultrasound-guided intra-amniotic injections for the treatment of developmental disorders, with improved formation of specific EDA1-dependent structures in dogs with XLHED., (Copyright © 2019 by The American Society for Pharmacology and Experimental Therapeutics.)

Objective: This study compared the clinical features, cardiac structure and function evaluated by echocardiography, cardiopulmonary response to exercise and long-term clinical outcomes between patients with heart failure (HF) induced by cancer therapy (CTHF) and heart failure not induced by cancer therapy (NCTHF)., Methods: We evaluated 75 patients with CTHF and 894 with NCTHF who underwent clinically indicated cardiopulmonary exercise testing, and followed these individuals for a median of 4.5 (3.0-5.8) years, during which 187 deaths and 256 composite events (death, heart transplantation and left ventricular (LV) assistant device implantation) occurred., Results: Compared with NCTHF, patients with CTHF were younger, with lower prevalence of cardiovascular comorbidities, higher LV ejection fraction (LVEF), but similar global longitudinal strain. LV diastolic function (higher E/e' ratio) and compliance (higher end-diastolic pressure/LV end-diastolic volume index ratio) were worse in CTHF and were both associated with adverse outcomes. Despite a favourable clinical profile, peak VO 2 and VE/VCO 2 slope were similarly impaired in CTHF and NCTHF. In multivariable Cox regression analysis including clinical characteristics, cardiopulmonary exercise testing variables and LVEF, CTHF was associated with a significantly higher risk of death (HR 2.64; 95% CI 1.53 to 4.55; p=0.001) and composite events (HR 1.79; 95% CI 1.10 to 2.91; p=0.019) compared with NCTHF., Conclusions: CTHF is characterised by a distinct clinical profile, better LVEF but worse LV diastolic properties, and similarly impaired global longitudinal strain, functional capacity and ventilatory efficiency. Accounting for differences in clinical characteristics, CTHF was associated with worse long-term prognosis than NCTHF., Competing Interests: Competing interests: AMS reports receiving research support from Novartis and Bellerophron, and consulting fees from Philips Ultrasound. The other authors have nothing to disclose., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2019. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Aims: To investigate the prognostic value of layer-specific global longitudinal strain (GLS) in predicting heart failure (HF) and cardiovascular death (CD) following acute coronary syndrome (ACS)., Methods and Results: In this retrospective study, 465 ACS patients underwent transthoracic echocardiography following percutaneous coronary intervention (PCI). The primary endpoint was the composite of HF and/or CD with a median follow-up time of 4.6 (0.2-6.3) years. During follow-up 199 patients (42.7%) suffered HF and/or CD (176 developed HF and 38 suffered CD). Absolute endomyocardial global longitudinal strain (GLSendo) (12% vs. 17%, P < 0.001), GLS (11% vs. 14%, P < 0.001), and epimyocardial global longitudinal strain (GLSepi) (9% vs. 13%, P < 0.001) were all reduced in patients with an adverse outcome. In multivariable Cox regressions, which included clinical baseline characteristics and conventional echocardiographic measurements, GLS obtained from all layers remained independently associated with the composite outcome; GLSendo [hazard ratio: 1.19 (1.10-1.28), P < 0.001, per 1% decrease], GLS [hazard ratio 1.24 (1.14-1.35), P < 0.001, per 1% decrease], and GLSepi [hazard ratio 1.26 (1.15-1.39), P < 0.001, per 1% decrease]. No other echocardiographic measures remained independently associated with the composite outcome in these models. Finally, GLS and GLSepi provided incremental prognostic information on the risk of developing the composite endpoint, when added to all other clinical and echocardiographic measures [adding GLS (c-statistics: 0.76 vs. 0.74, P = 0.048) or adding GLSepi (c-statistics: 0.76 vs. 0.74, P = 0.039)]., Conclusion: In ACS patients, layer-specific strain provides independent prognostic information regarding risk of developing HF and/or CD. Furthermore, only GLS and GLSepi provided incremental prognostic information when added to all other significant predictors.

Mutations in several lipid synthetic enzymes that block fatty acid and ceramide production produce autosomal recessive congenital ichthyoses (ARCIs) and associated abnormalities in permeability barrier homeostasis. However, the basis for the phenotype in patients with NIPAL4 (ichthyin) mutations (among the most prevalent ARCIs) remains unknown. Barrier function was abnormal in an index patient and in canines with homozygous NIPAL4 mutations, attributable to extensive membrane stripping, likely from detergent effects of nonesterified free fatty acid. Cytotoxicity compromised not only lamellar body secretion but also formation of the corneocyte lipid envelope (CLE) and attenuation of the cornified envelope (CE), consistent with a previously unrecognized, scaffold function of the CLE. Together, these abnormalities result in failure to form normal lamellar bilayers, accounting for the permeability barrier abnormality and clinical phenotype in NIPA-like domain-containing 4 (NIPAL4) deficiency. Thus, NIPAL4 deficiency represents another lipid synthetic ARCI that converges on the CLE (and CE), compromising their putative scaffold function. However, the clinical phenotype only partially improved after normalization of CLE and CE structure with topical ω-O-acylceramide because of ongoing accumulation of toxic metabolites, further evidence that proximal, cytotoxic metabolites contribute to disease pathogenesis., (Copyright © 2018 American Society for Investigative Pathology. Published by Elsevier Inc. All rights reserved.)

Introduction: In plaque psoriasis, the benefit of topical steroids is well established. The vehicle formulation of topical steroids may also provide benefit in addition to the effects of the steroid itself. DFD-01 (betamethasone dipropionate spray, 0.05%) is a formulation composed of a topical steroid in an emollient-like vehicle that enhances penetration to the target site of inflammation in the skin. The aim of this study was to assess the effect of DFD-01 and its vehicle on skin hydration and barrier function in compromised skin and to evaluate its effect on flexibility in healthy skin., Methods: Eighteen healthy white volunteers were enrolled in each of two studies. In Study 1, dry shaving of volar forearms created a compromised skin barrier, through which transepidermal water loss (TEWL) was measured using an evaporimeter. Capacitance, a measure of epidermal hydration, was also measured at baseline and at 1, 2 and 4 h after application of DFD-01 or its vehicle formulation. In Study 2, intact skin flexibility was tested with a cutometer before and at 1, 2 and 4 h after application of DFD-01 or vehicle., Results: In Study 1, both DFD-01 and its vehicle were effective at reducing TEWL through the compromised stratum corneum. Capacitance measurements confirmed this finding; razor-chafed skin treated with either DFD-01 or vehicle exhibited levels of skin hydration similar to unshaved control skin. Study 2 found softening and greater flexibility of normal skin treated with either DFD-01 or vehicle compared with nontreated control skin samples., Conclusions: These tests suggest that the DFD-01 formulation and its vehicle are each effective at retaining moisture within a damaged skin barrier and for softening and increasing the flexibility of intact skin., Funding: Dr. Reddy's Laboratories.

Though cardioprotective, niacin monotherapy is limited by unpleasant cutaneous symptoms mimicking dermatitis: niacin-associated skin toxicity (NASTy). Niacin is prototypical of several emerging drugs suffering off-target rubefacient properties whereby agonizing the GPR109A receptor on cutaneous immune cells provokes vasodilation, prompting skin plethora and rubor , as well as dolor , tumor , and calor , and systemically, heat loss, frigor , chills, and rigors. Typically, NASTy effects are described by subjective patient-reported perception, at best semi-quantitative and bias-prone. Conversely, objective, quantitative, and unbiased methods measuring NASTy stigmata would facilitate research to abolish them, motivating development of several objective methods. In early drug development, such methods might better predict clinical tolerability in larger clinical trials. Measuring cutaneous stigmata may also aid investigations of vasospastic, ischemic, and inflammatory skin conditions. We present methods to measure NASTy physical stigmata to facilitate research into novel niacin mimetics/analogs, detailing characteristics of each technique following niacin, and how NASTy stigmata relate to symptom perception. We gave niacin orally and measured rubor by colorimetry and white-light spectroscopy, plethora by laser Doppler flowmetry, and calor / frigor by thermometry. Surprisingly, each stigma's abruptness predicted symptom perception, whereas peak intensity did not. These methods are adaptable to study other rubefacient drugs or dermatologic and vascular disorders., (Copyright © 2017 by the American Society for Biochemistry and Molecular Biology, Inc.)

Tissue implant management can be labor intensive because of multiple storage locations and cumbersome tracking systems. The purpose of this quality improvement (QI) project was to enhance patient safety and nursing satisfaction by upgrading our tissue-management facility and processes. We created a centralized storage room for tissue implants and staffed this room during all shifts. Tissue management was executed using tracking software and transportation devices that supported tissue receipt, storage, disposition, documentation, and reporting. Our project resulted in our full compliance with tissue implant requirements from the US Food and Drug Administration (FDA) and The Joint Commission. We also reduced our documentation error rate from 3% to less than 1%, and decreased the tissue-expiration rate by 1.1%. Tissues are now delivered to ORs, which allows RNs to focus on patient care rather than retrieval of implants. Monitoring of the tissue inventory has improved, resulting in the reduction of tissue wastage., (Copyright © 2016 AORN, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: To compare the relative gentleness of a silicone tape to a paper tape in healthy infants and children., Design: A randomized, grader-blinded, comparative study., Subjects and Setting: The sample group comprised 24 healthy infants and children 9.1 to 46.7 months of age (mean ± SEM, 34.0 ± 2.21). The study was conducted at a dermatological research facility (cyberDERM, Inc) located in Broomall, Pennsylvania. All volunteers were recruited from the surrounding community., Methods: Tapes measuring 1 × 1.5 inches were randomly applied to the left and right intrascapular regions of the upper back. Tapes were removed in a standardized fashion after 24 hours. The primary study outcome, gentleness, was based on visual assessments of skin damage, discomfort, and quantification of keratin removal. Four-point scales were used to assess skin damage, and a 10-point Faces, Legs, Activity, Cry, and Consolability instrument was used to assess discomfort. Secondary assessments included hair removal, tape edge-lift assessments, and parent preference for either tape., Results: There was a significantly lower mean ± SEM erythema response for the silicone tape (0.93 ± 0.14 vs 1.35 ± 0.11, P = .0129) than for the paper tape. No measurable epidermal stripping occurred with the silicone tape compared to a mean ± SEM response of 0.29 ± 0.11 for the paper tape (P = .0039). Discomfort was significantly lower (P = .0002) for the silicone tape as compared to the paper tape (Faces, Legs, Activity, Cry, and Consolability score mean difference from baseline 0.5 vs 3.3, P = .0002). Keratin removal was significantly less with the silicone as compared to paper tape (8.7 ± 0.5 μg/mL vs 15.2 ± 1.3 μg/mL, P < .0001). Few hairs were removed with either tape. There was significantly less (P < .0001) edge-lift with the paper tape than the silicone tape; no statistically significant differences in parent preferences for silicone versus paper tapes were measured (P = .3359)., Conclusions: Gentleness assessments favored the silicone tape compared to a paper tape and warrant further clinical investigation in the neonatal intensive care unit.

Background: Dry skin in the winter has been reported to involve scaling, defects in water holding and barrier functions, and decreased ceramide (CER) levels in the stratum corneum (SC). We previously reported that a Eucalyptus extract promotes CER synthesis in cultured keratinocytes and accelerates the recovery of hydration in a barrier-disrupted model of human skin., Aims: One of the objectives was to examine the CER profile and its contribution to the relief of dry skin. The other objective was to assess the efficacy of a Eucalyptus extract to treat dry skin., Patients/methods: Twenty subjects with dry skin on their legs were assessed and their CER profiles were analyzed using tape-stripping. A moisturizer with a Eucalyptus extract was assessed for its effects on dry skin using a leg regression methodology comprising 28 days of treatment and 14 days of regression., Results: Indicators of dry skin conditions (conductance, dryness, roughness, and scaliness) strongly correlated with the level of CER, CER [NP], and CER[NH]. Treatment with the Eucalyptus extract significantly improved conductance (3 days after regression) and transepidermal water loss (14 days after regression) compared with the placebo. After 28 days of treatment with the Eucalyptus extract, the level of CER in the SC did not increase, but CER [NP] did increase., Conclusions: These results suggest that not only the level of CER, but also specific CER species strongly contribute to dry skin relief and products that increase those are useful to improve dry skin conditions., (© 2013 Wiley Periodicals, Inc.)

Purpose: To compare gentleness of a silicone tape to a paper tape and to an untreated control., Design: Controlled, randomized, grader-blinded cohort trial., Subjects and Setting: The sample group comprised 28 healthy volunteers aged 55 years and older (median age = 63 years) with a Fitzpatrick Skin Type of I, II, or III. All volunteers were recruited from the greater Philadelphia area and the study was conducted at a dermatological research facility specializing in noninvasive instrumental measurements., Methods: Tapes were applied and removed daily (excluding weekends) to 2 of 3 sites on the left and right volar forearms over an 11-day period. The center site on each forearm was left untreated and tapes were randomized to the proximal and distal sites. The primary assessment was transepidermal water loss (TEWL); secondary assessments included erythema/edema, denudation/skin-stripping, and subject self-evaluations. Study personnel conducting the primary and secondary assessments were not involved with treatments to maintain the blinded nature of the study. The identity of the 2 tapes was not revealed to the subjects until after conclusion of the study., Results: On day 11 the mean TEWL value for the paper tape was significantly higher than that for both the untreated control and silicone tape (P < .001). End-of-study mean TEWL values were 2.65 ± 0.68 g/mh for the silicone tape, 6.85 ± 4.97 g/mh for the paper tape, and 3.73 ± 1.19 g/mh for the untreated control. At all assessments, the silicone tape exhibited net changes from baseline that were significantly less than the paper tape (P < .05 day 1, P < .001 days 4, 7, and 11) and similar for the untreated control. Only at days 4 (P < .01) and 11 (P < .001) was the paper tape significantly higher than that for the untreated control. Throughout the study, both tapes exhibited mean TEWL values within the range of normal intact forearm skin, indicating that both tapes were gentle. No differences in erythema/edema scores occurred but the silicone tape resulted in lower denudation/skin-stripping scores than the paper tape at days 4 to 11 (P < .0001). Self-assessment of pain at removal was low for both tapes but significantly lower for the silicone tape (days 1-7, P = .02; day 11, P = .009). Forty-four percent of participants expressed a preference for the silicone tape as compared to the paper tape (19%), with 37% stating no preference., Conclusions: Based on TEWL assessment of disruption of the stratum corneum water barrier, the silicone tape proved gentler to the skin than the paper tape. After 9 applications and removals over 11 days of study, the silicone tape was similar to the untreated control, whereas the paper tape exhibited significantly higher mean TEWL values than both the untreated control and the silicone tape. Expert grader assessments corroborate these findings. These data indicate that the silicone tape may provide additional gentleness when it is clinically needed.

Background: Adhesion of incise drapes is important at the wound edge, where the skin and drapes are contiguous with the wound. Separation of incise drapes from the skin has been reported to be associated with a sixfold increase in the infection rate compared with surgical procedures in which the drape did not lift off. The present study sought to determine whether the choice of preoperative skin preparation affects the adhesion of various incise drapes., Methods: Following randomization, the backs of twenty-two healthy volunteers were prepared with two skin preparations, 3M DuraPrep Surgical Solution Patient Preoperative Skin Preparation or ChloraPrep with Tint (Scrub Teal) Patient Preoperative Skin Preparation, according to the label directions. Sample strips (12.7 × 76.2 mm) of three different drapes were applied to the prepared areas and were covered with gauze soaked with saline solution for thirty minutes to simulate a fluid challenge. Drape samples were mechanically removed with use of a peel tester based on an international standard for testing peel adhesion of pressure-sensitive tape. Adverse events were monitored and the skin condition was observed. The primary outcome was drape adhesion, measured as the peel strength in units of gram-force. Outcomes were assessed according to drape type and skin preparation with use of mixed-model analysis of variance., Results: Skin prepared with DuraPrep solution had significantly greater drape adhesion (mean peel strength, 181 gf) compared with skin prepared with ChloraPrep (79 gf, p < 0.001). Although maintaining good adhesion is important, an incise drape that has excessive adhesion may cause skin irritation. Regardless of the skin preparation used, the skin reaction at the application site ranged from none to moderate erythema, and in no instance constituted an adverse event that required treatment., Conclusions: The data suggest that the type of skin preparation affects drape adhesion. For surgical procedures in which incise drapes are used, choosing a skin preparation that enhances drape adhesion may minimize drape lifting and the potential for wound contamination.

Objective: To test the hypothesis that topically applied calcium glycerophosphate (CGP) would improve the appearance of the wound following bilateral knee replacement., Method: Healthy patients, aged 45-75 years, scheduled for bilateral total-knee replacement surgery were recruited into the study. One knee was randomly assigned to the treatment group, while the contralateral knee was designated the control (standard care). Subjects were instructed to apply a preparation of 10% CGP in an aqueous lotion to the treated knee once daily for 42 days, starting at the third postoperative day. Functional sealing and cosmetic appearance of the incision were evaluated by two surgeons by direct examination of the patient and then by two experienced assessors from photographs. The investigators qualitatively scored the intensity and extent of erythema along the incision and over the entire knee, the appearance of visible oedema along the incision and over the knee, and the overall clinical impression of wound healing. All four assessors were blinded to the subjects' allocation and the latter two assessors to the initial investigators' assessments. Subjects were also followed up for an additional 46 weeks, giving a total study duration of 12 months., Results: Twenty patients completed the study. Statistical analysis showed that both the area and intensity of erythema along the incision were significantly reduced in the treated vs untreated knee over the entire study period. The analysis further showed that treatment significantly reduced oedema, both along the incision and across the entire knee. The differences were most marked at the seventh postoperative day and diminished with time. No adverse effects were observed for any patient, in either treated or untreated knees., Conclusion: These data demonstrate that postoperative application of 10% CGP could improve the appearance of the wound following total knee arthroplasty.

Background: Lower serum vitamin D (25(OH)D) among individuals with African ancestry is attributed primarily to skin pigmentation. However, the influence of genetic polymorphisms controlling for skin melanin content has not been investigated. Therefore, we investigated differences in non-summer serum vitamin D metabolites according to self-reported race, genetic ancestry, skin reflectance and key pigmentation genes ( SLC45A2 and SLC24A5) ., Materials and Methods: Healthy individuals reporting at least half African American or half European American heritage were frequency matched to one another on age (+/- 2 years) and sex. 176 autosomal ancestry informative markers were used to estimate genetic ancestry. Melanin index was measured by reflectance spectrometry. Serum vitamin D metabolites (25(OH)D 3 , 25(OH)D 2 and 24,25(OH) 2 D 3 ) were determined by high performance liquid chromatography (HPLC) tandem mass spectrometry. Percent 24,25(OH) 2 D 3 was calculated as a percent of the parent metabolite (25(OH)D 3 ). Stepwise and backward selection regression models were used to identify leading covariates., Results: Fifty African Americans and 50 European Americans participated in the study. Compared with SLC24A5 111 Thr homozygotes, individuals with the SLC24A5 111 Thr/Ala and 111 Ala/Ala genotypes had respectively lower levels of 25(OH)D 3 (23.0 and 23.8 nmol/L lower, p-dominant=0.007), and percent 24,25(OH) 2 D 3 (4.1 and 5.2 percent lower, p-dominant=0.003), controlling for tanning bed use, vitamin D/fish oil supplement intake, race/ethnicity, and genetic ancestry. Results were similar with melanin index adjustment, and were not confounded by glucocorticoid, oral contraceptive, or statin use., Conclusions: The SLC24A5 111 Ala allele was associated with lower serum vitamin 25(OH)D 3 and lower percent 24,25(OH) 2 D 3 , independently from melanin index and West African genetic ancestry.

Background/aims: The ability to anticipate skin damage and subject/patient discomfort due to the removal of adhesive materials without human testing is currently limited. While standardized laboratory methods have been developed, their ability to model and predict the interaction with relevant living substrate is imperfect. The aim of this study was to assess the adhesion of various materials as a function of time using the abdomen as the body site, and determine if a relationship existed with skin damage and subject discomfort., Methods: Strips of six different materials used in medical devices and known to have different adhesive properties in the laboratory setting were tested in this study. The strips were adhered to the abdomens of normal volunteer subjects for varying periods of time. Peel force was measured under conditions developed to lessen the influence of skin elasticity. Disturbance of the skin barrier was assessed by measuring transepidermal water loss; erythema by reflectance L*a*b* measurements; skin cells removal by quantitation of dyed cells adhering to the test strips; and discomfort using subject self-assessment., Results: When measured at times from 30 min to 72 h after application, the peel force was highest for materials at 30 min. The peel force for one of the six materials, designated F, was clearly higher than the others at time points from 30 min to 48 h after application. Interestingly, this material caused less disruption to the skin barrier and was reported to cause less discomfort., Conclusions: In this system, there was not a correspondence between adhesion as measured by peel force and skin damage or self-report of discomfort. Further investigations will be required to establish the predictive value of other biophysical measurements and discomfort.

A topical gel containing a proprietary mixture of over 110 growth factors, cytokines, and soluble matrix proteins secreted by human dermal fibroblasts was evaluated for safety and efficacy in the treatment of mild to severe facial photodamage. In a double-blind study, 60 subjects were randomly assigned to receive either active gel or the vehicle and applied twice daily for 6 months along with a moisturizing cleanser and sunscreen. Efficacy (profilometry, photography, and clinical assessment) and safety (adverse event reporting) measures were evaluated at 0, 3, and 6 months. Treatment with the active gel for 3 months produced greater reduction in fine lines and wrinkles than the vehicle treatment as measured by objective and subjective assessment techniques. The results were either statistically significant (P < or = .05) or trending towards statistical significance (P < or = .1). This study demonstrates that addition of a topical formulation of growth factors and cytokines to a basic skin care regimen reduces the signs of photoaging.

Petrolatum-based ointments often are used to treat and prevent incontinence dermatitis. However, anecdotal reports indicate that petrolatum ointments may affect the absorbency of disposable briefs also commonly used in incontinence management. To examine whether petrolatum ointments clog a commonly used absorbent brief, a randomized, balanced-block design study was conducted in a controlled laboratory setting to compare the brief-clogging potential of three petrolatum ointments to a non-alcohol barrier film. Test products were applied to 6-cm x 6-cm test sites on the volar forearms of 16 volunteers. Pre-weighed mini briefs were applied to the test sites in a manner that simulates normal brief wear. After 5 minutes of wear, the mini briefs were weighed to determine percent of product transfer from skin to mini brief. The mini briefs then were reapplied to the same test sites and a synthetic urine solution was introduced between the skin and the mini brief. Mini briefs subsequently were removed to determine fluid uptake by weight. Results indicate significant differences between the four test products (P < 0.01) both in percent transfer and in mini brief fluid absorption. From 59% to 69% of the petrolatum-based products transferred from the skin to the mini briefs and a 54% to 90% reduction in fluid uptake was noted, as determined by weight. The non-alcohol barrier film did not transfer to the mini brief and fluid uptake was minimally affected. Further study in the clinical and practice settings to determine the effect and consequences of barrier product transfer on absorbent garments is warranted.

Background/aims: This study investigated the effect of specific, commonly used diaper types on scrotal temperatures in normal healthy, young boys. These included both modern disposable and reusable diapers as well as various types of protective outer coverings that are in common use in both North America and Europe, Methods: Scrotal and skin surface temperatures were continuously monitored in healthy, young males using a computerized data-logging system based on temperature probes specifically designed for paediatric studies. These systems could be used either tethered to the PC or made completely portable depending upon the age and activity of the child being measured. Based on our results from several pilot studies, it became clear that the best way to determine if disposable and reusable diapers differ with regard to their impact on scrotal temperatures is to run these comparisons under controlled laboratory conditions where "diaper type" was the primary variable. A 2-h time period was chosen to ensure that sufficient time had elapsed for thermal equilibrium to be established under the diapers. We also felt it necessary to study the impact of urination and simulated this condition over the last 15 min using standardized methods. In addition to the skin surface temperatures, we also measured the temperature of the tympanic membrane using an infrared thermometer as an estimate of "core" temperature for each individual at various times during the session., Results and Conclusions: In this study, we have clearly shown that scrotal temperatures are the same whether the child is wearing disposable or reusable cloth diapers with a protective cover. The only situation in which scrotal temperatures were found to be lower is when the cloth diaper is used alone without a protective cover but this is not representative of how these products are actually used. We also found that on average scrotal temperatures are significantly lower than core for each diaper type. Occasionally, we did see individuals in which the maximal scrotal temperatures approached core temperatures but in every case the thermal sensors were soiled by a bowel movement. We also found that skin surface temperatures increased not only when covered by a diaper but also due to the thermal insulation provided by outer garments and blankets.

Background: Hand-cleansing products that are milder to the skin of health care personnel are being developed, but the available methodologies to appropriately evaluate these products and quantify differences are not generally being applied in well-controlled studies., Methods: Two randomized, blinded, bilateral comparison studies evaluated skin condition during use of 2 antiseptic hand preparation products: a new 1% chlorhexidine gluconate (CHG)/61% wt/wt ethanol antiseptic hand preparation in a unique emollient system for waterless/brushless application and a conventional 4% CHG antimicrobial product that is applied with water and a scrub brush. Trained technicians applied treatments 6 times (for a surgical scrub study) or 24 times (for a personnel handwash study) daily to the hands of healthy volunteers during 5 days of controlled washing. An expert grader evaluated skin for dryness, erythema, and roughness. Subjects completed a self-assessment questionnaire on skin condition. Transepidermal water loss was measured by an evaporimeter, and the skin surface hydration level was measured by an electrical conductance meter., Results: Fifty-eight subjects were enrolled in the 2 studies and received both treatments. In general, skin treated with the waterless CHG/ethanol product scored significantly (P <.004) better on evaluations of visual dryness and erythema and showed greater improvement in the level of hydration (P <.003). In the health care personnel handwash study, transepidermal water loss was less than that for skin treated with the conventional CHG product (P <.002). Subject assessments showed similar results (total score, P <.007)., Conclusions: All 3 approaches of expert grader evaluation, subject assessment, and instrumentation were in concordance, demonstrating that the waterless CHG/ethanol product was gentler to skin than the conventional CHG product.

Two double-blind, randomized, split-face studies have been performed to compare the facial tolerability of topical retinoids in volunteers with sensitive skin. In one study, subjects applied tazarotene 0.1% gel to one side of their face and tretinoin 0.1% gel microsponge, tretinoin 0.025% gel, or adapalene 0.1% gel to the other side of their face, for up to 29 days. Increases in facial dryness and erythema were comparable among all retinoids. Some subjects in each treatment group experienced levels of retinoid-associated irritation that required temporary suspension of, or reduction in, treatment. Facial dryness and erythema tended to be greater in these subjects than in those who tolerated the regimen without change, suggesting that the need to discontinue or modify treatment depends more on the individual than on any major inherent differences in the irritant potential of these retinoids. A second study compared once-daily versus alternate-day tazarotene 0.1% gel therapy. Tolerability was superior when initiating therapy with the alternate-day regimen.

Background: A variety of instruments are available that can objectively assess physical parameters of the skin such as strength, firmness, elasticity, hydration, and color, often undetected by clinical assessment., Objective: To assess the physical properties of healed acute and chronic wounds using several noninvasive instruments., Methods: Four patients with healed acute wounds and four patients with healed chronic wounds were studied using ballistometric, impedance, levarometric, and spectrophotometric measurements., Results: In general, scars were harder, less elastic, dryer, and more erythematous than control skin. These differences were more pronounced in healed chronic wounds., Conclusion: A scar from an acute surgical wound becomes softer, more elastic, dryer, less erythematous, and less pigmented as it ages. In contrast, chronic wound scars become harder as they age. These different properties of healed acute wounds and healed chronic wounds may be a result of the different healing processes in each wound type.

Exaggerated test conditions were frequently used to investigate the cutaneous tolerance of detergent products in the past. As the sensitivity of newly designed biometric methods is steadily improving, the trend towards more realistic test conditions should be encouraged. A hand immersion test under laboratory-controlled usage conditions is presently described, fulfilling such principles. Panelists soaked their hands in 2 different hand dishwashing liquids, 2x daily for 10 min each (with successive in-solution/out-of-solution cycles) for 4 consecutive days. Products were at usual dilution for dishwashing liquids and were randomized between the dominant and non-dominant hands of panelists. Visual scoring of erythema and dryness developing on the whole hands (scoring scales including interdigital areas and joints) during the week did not allow discrimination between the 2 products. However the dominant hands were significantly more susceptible to alterations than the non-dominant hands, regardless of product attribution. In contrast, skin electrical measurements (Corneometer CM800 and Skicon 200) on the dorsum of the hands (muscle mass between thumb and index) and squamometry analysis of tape stripping (harvested from the same site) yielded significant differences between the 2 products. In conclusion, a hand immersion test under realistic conditions has been described, which discriminates between products when sensitive assessment methods are used to explore skin sites partially protected from daily-life skin aggressions.

Background/aims: Excessive skin hydration resulting from wet undergarments is a major cause of diaper rash in children and contributes to severe dermatitis in incontinent adults. Advancements in absorbent technology have led to diapers and incontinent garments that not only absorb urine, but also transfer it to different regions, and lock it away from the skin. The purpose of the present study was to develop a reliable method to assess the effectiveness of absorbent articles in mitigating skin hydration., Methods: Disposable diapers with different absorbent structures were wrapped around the forearms of adult volunteers, loaded with urine substitute, and held in place for 1 h. Hydration of the volar region was measured by evaporimetry and compared with that of skin in the diaper region of children who had worn control loaded diapers in the usual way. The amount of fluid retained in various diaper layers and in the superabsorbent polymer core was measured., Conclusions: Evaporative water loss measurement on adult forearms was shown to be a reliable test for comparing the effectiveness of absorbent articles in preventing excessive skin hydration provided that 1) the complete garment was used and 2) fluid was loaded in a manner that simulated normal urination. Skin on adult forearms and skin in the diaper region of children were concordant in their response to wet diapers. Skin wetness was directly related to the amount of liquid retained in absorbent layers close to the skin.

Background: Much has been said about the effects of glycolic acid with little scientific evidence to substantiate the findings. OBJECTIVE. This study reports on the clinical and histological effects of glycolic acid at pH levels 3.25, 3.80, and 4.40, and at 3.25%, 6.50%, 9.75%, and 13.00% on ichthyotic/xerotic skin., Methods: Product treatment consisted of a 2-week washout period followed by 3 weeks of product application (BID) with A 1-week regression period. Shave biopsies and clinical evaluations for dryness, moisturization, and transepidermal water loss were made at baseline, 1, 2, and 3 weeks of use, and at the regression period., Results: Clinically, ichthyotic/xerotic skin was normalized with histologic evidence of stratum corneum thinning, viable epidermal thickening, and marked increases in glycosaminoglycan and collagen content., Conclusion: All pH levels and concentrations demonstrated significant improvement in the condition of the skin with trends implying that increasing the pH increases efficacy.

Background: Epidemiologic studies indicate that after using soaps and other personal care products, many consumers experience irritation. In 50% of the cases the feelings of skin dryness, itching, and stinging occur in the absence of visible signs of irritation., Objective: We sought to determine the relation between self-perceived sensory responses of panelists to cleansing products and clinical signs of irritation., Methods: A combination of exaggerated arm-washing methods was designed to induce clinical signs of irritation with psychometric techniques developed to quantify sensations., Results: Two studies demonstrated that panelists could reproducibly differentiate between products on the basis of the sensations they felt and that there was a significant correlation (frequently r > 0.80) between these and the observable signs. In the case of skin dryness panelists differentiated products several washing cycles before observable differences were detected., Conclusion: Sensory evaluations of irritation yield additional information on soap and detergent irritancy beyond clinical observations and expand understanding of the irritation process.

Down's Syndrome (DS) is a genetic disorder involving mental retardation which is reported to be a condition of accelerated aging. However, few studies exist which examine age-dependent changes in DS and these studies fail to include a control group. In the present study a non-invasive, painless, and easily obtainable measure reflecting age-dependent topographical changes of the skin (skin wrinkling) was obtained in 15 DS subjects, 14 developmentally disabled (DD) (mentally retarded) controls (DD controls) and 16 healthy controls of similar ages ranging from 22 to 51 years. The healthy control group failed to show correlations of skin measures with age, as predicted for the age-range of these subjects, based on results of previous studies. However, the DS group showed significant correlations of all skin measures from relatively non-sun-exposed and sun-exposed skin sites, with age. The DD control also showed significant correlations with age of several but not all skin sites and the correlation coefficients tended to be less than that of the DS; at least, when contrasted with the healthy controls the DS showed greater values of several skin measures suggestive of accelerated skin wrinkling. These results provide evidence for accelerated aging of the skin, and possibly greater effects of sun-exposure on skin wrinkling, in DS and possibly (DD) individuals in contrast to healthy individuals without a genetic disorder and without mental retardation.

Ten patients with portwine stains (PWS) with test sites previously exposed to an argon laser were evaluated and subsequently treated with five pulsed dye (585 nm) laser treatments over a 10 month period. Clinical assessments, skin surface texture analyses using optical profilometry, and light microscopic histological evaluations were performed prior to commencement and at the end of the study in all ten patients. A change in the skin texture with return of skin markings approximating those of normal skin measured by optical profilometry was observed in the argon treated PWS skin following pulsed dye laser treatments.

Differences in the response of distinct layers of the skin to surfactants were probed using a modification of the Frosch and Kligman soap chamber test. Soap and other surfactant-containing cleansers were applied to the skin for 2 consecutive days. Transepidermal water loss showed that the stratum corneum is readily damaged even by a mild insult when no erythema is induced. A more severe treatment, such as 24-h exposure to a 5% soap solution, induced the maximal level of barrier damage but a submaximal level of erythema. Even 2 days of exposure to 5% soap does not elicit a maximal erythema response. These results suggest that the stratum corneum is more readily damaged than the dermis, which is not unexpected because the stratum corneum is the initial point of contact between surfactant and skin. Furthermore, this study indicates that for discriminating among mild products, when a small degree of irritation is induced, the most effective measure is stratum corneum damage assessed by evaporimetry. However, for evaluating more irritating products, erythema is probably the more discriminating evaluation technique.

Computerized image analysis of silicone replicas, a reproducible, objective technique for measuring skin topography, was used in addition to clinical measures in two multicenter, double-blind, randomized, controlled studies of tretinoin emollient cream, a new formulation for treating photodamaged skin. Previously, the skin replica technique had been successfully used in a pilot study of tretinoin 0.05% cream by one investigator. In the present studies, subjects treated for 24 weeks with tretinoin emollient 0.05% cream consistently showed more improvement in skin topography than did vehicle-treated patients. A 0.01% concentration of tretinoin emollient cream also improved skin topography to a greater extent than the vehicle, while the lowest concentration tested (0.001%) showed little difference from vehicle. These results, reflecting a smoothening of the skin surface in tretinoin emollient cream-treated subjects, were consistent with clinical data showing greater improvement in fine wrinkling and roughness after tretinoin emollient cream therapy than after vehicle therapy. Findings from these multicenter studies confirm the value of the skin replica technique and help establish the efficacy of tretinoin emollient 0.05% cream for photodamaged skin.

A method is described for quantification of the bacterial flora on the hand surface. Computer-assisted image analysis of bacterial growth of large full-hand touch plates provides a quantifiable measure of the bacterial flora on the hand surface. Image analysis pixel intensity values showed a significant correlation (P less than 0.0001) with colony forming unit values determined by the glove juice method. Image analysis of impressions from hands treated with various antimicrobial agents in detergent bases showed that 4% chlorhexidine gluconate produces a 96% reduction after a 30 s washing and 98% reduction after a 3 min washing while 7.5% povidone-iodine and 1% triclosan produce a 77% and 70% reduction after 3 min respectively, and 70% isopropanol produces a 98% reduction after a 30 s wash.

Sunscreens with different sun protection factors were examined for their ability to prevent sunburn cell formation in human skin exposed to ultraviolet radiation from a xenon solar simulator. There was either complete or partial protection against the cytotoxic effects of ultraviolet radiation. Protection was related to the sun protection factor of the sunscreen and to the dose of radiation administered.

Epidermal cell renewal was assessed nonintrusively in normal human volunteers by monitoring the disappearance of a fluorescent marker dye, dansyl chloride, from the skin surface. In young adults, stratum corneum transit time was approximately 20 days, whereas in older adults this was lengthened by more than 10 days. Because the number of horny cell layers does not change with age, these data indicate that the increased stratum corneum transit time was a reflection of diminished epidermal cell proliferation. Additional analysis indicated that the decline in epidermal cell renewal may not occur at a constant rate throughout the adult lifespan but, instead, remains relatively constant in the younger years and then begins to drop dramatically after age 50. This suggests that a linear-spline model rather than a simple linear model may be more appropriate for analyzing these results.

Exposure of normal skin to visible light (400-700 nm) resulted in the induction of immediate pigment darkening (IPD), immediate erythema and a persistent (delayed) tanning reaction. The intensity of pigmentation and time course of the reaction were monitored by measuring chromaticity coordinates. Both IPD and immediate erythema faded over a 24-h period but, unlike erythema, the pigmentation did not totally disappear and the residual tanning response remained unchanged for the rest of the 10-day observation period. The threshold dose for IPD with visible light was between 40 and 80 J/cm2, while the threshold dose for "persistent" pigmentation was greater than or equal to 80 J/cm2.