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Objective: To evaluate the efficacy and safety of darbepoetin alfa dosed every-other-week (Q2W) to treat anemia in subjects with chronic kidney disease (CKD), not receiving dialysis, who were naïve to erythropoiesis-stimulating agent (ESA) therapy.Research Design and Methods: This was an open-label, multicenter, single-arm study enrolling ESA-naïve CKD subjects with baseline hemoglobin (Hb) < 11.0 g/dL. Q2W darbepoetin alfa treatment was initiated at a dose of 0.75 microg/kg and titrated to achieve and maintain Hb levels at 11.0-13.0 g/dL. Treatment was administered from week 1 to week 19.Main Outcome Measures: The primary endpoint was the proportion of subjects who achieved Hb > or = 11 g/dL at any study visit, except in week 1. Hb levels, darbepoetin alfa dose, and safety were also assessed.Results: Of the 128 subjects who received at least one dose of darbepoetin alfa and of the subjects who completed the study, 118 (92%) and 112 (97%), respectively, achieved a Hb > or = 11 g/dL in a median time of 5 weeks. Median darbepoetin alfa dose at week 1 and at the time of achieving a Hb > or = 11 g/dL were 60 and 80 microg, respectively. Darbepoetin alfa was well-tolerated, and short-term adverse events were consistent with those expected in CKD subjects.Conclusions: This study demonstrates that de novo Q2W darbepoetin alfa was effective in correcting and maintaining Hb levels in ESA-naïve subjects with CKD who were not receiving dialysis. Study limitations, including lack of a control arm for the study and multiple race information for subjects, must be considered in interpreting the results.Clinical Trial Registration: ClinicalTrials.gov, NCT00112008. [ABSTRACT FROM AUTHOR]

Lori A Brightman,1 Roy G Geronemus,1 Kavitha K Reddy2 1Laser and Skin Surgery Center of New York, New York, NY, USA; 2Department of Dermatology, Boston University School of Medicine, Boston, MA, USA Abstract: Port-wine stains are a type of capillary malformation affecting 0.3% to 0.5% of the population. Port-wine stains present at birth as pink to erythematous patches on the skin and/or mucosa. Without treatment, the patches typically darken with age and may eventually develop nodular thickening or associated pyogenic granuloma. Laser and light treatments provide improvement through selective destruction of vasculature. A variety of vascular-selective lasers may be employed, with the pulsed dye laser being the most common and well studied. Early treatment produces more optimal results. Advances in imaging and laser treatment technologies demonstrate potential to further improve clinical outcomes. Keywords: laser, port-wine stain, capillary vascular malformation, vascular birthmark, selective photothermolysis, photodynamic therapy, intense pulsed light

Traumatic tattoos can occur when foreign pigment particles are embedded within the dermis, sometimes resulting as traumatic events. Traditional treatment modalities, including surgical excision, cryosurgery, electrosurgery, dermabrasion, CO 2 lasers, and argon lasers, have limitations such as nonselectivity for pigment and risks of scarring and discoloration. We present the case of a patient who developed a postoperative tattoo after a minimal access cranial suspension facelift procedure that subsequently completely resolved after treatment with the high-powered 1064-nm picosecond laser. The patient achieved complete resolution of the postoperative tattoo after five laser treatments without adverse events or recurrence of pigmentation on follow-up. High-powered 1064-nm picosecond laser can serve as a fast, safe, and effective modality that in our clinic has become the first-line treatment for traumatic tattoos, and in our patient led to high satisfaction., Competing Interests: Roy Geronemus is on the medical advisory board for Lutronic. All the other authors have no financial interest to declare in relation to the content of this article., (Copyright © 2024 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of The American Society of Plastic Surgeons.)

Background: Dyschromia can be caused by abnormalities in the increased production and/or reduced clearance of pigmentation in the skin. Causes of hyperpigmentation include excessive sun exposure, medications, hormones, post-inflammatory hyperpigmentation (PIH), and medical disorders, such as melasma. A novel topical product was recently developed, which contains actives that have been validated through in vitro studies to counteract various steps in the pigmentation pathways, including photodamage, PIH, and melasma. This study evaluates the safety and efficacy of this product for facial dyschromia., Study Design: Subjects with mild to severe facial dyschromia were enrolled to receive either the novel topical product with PATH-3 Technology (Alastin Skincare, Carlsbad, CA) or hydroquinone 4% topical to apply twice daily. Both cohorts received cleanser, sunscreen, and moisturizer. Follow-up occurred at weeks 4, 8, and 12. Blinded investigators used the modified Melasma Area Severity Index (mMASI) and modified Griffiths scales at baseline and final follow-up. Tolerability assessments and subject questionnaires were completed., Results: Forty-three subjects were enrolled and randomized to either the novel topical product (n=22) or hydroquinone 4% (n=21) cohort. At week 12 follow-up, subjects using the novel topical product had significant improvements in mMASI scores for the right cheek (P=0.0097), left cheek (P=0.0123), combined cheeks (P=0.0019), and total facial area (P=0.0046). In contrast, subjects using hydroquinone 4% had no significant improvements in any of these areas. Although both cohorts demonstrated improvements in dyschromia and skin tone, the novel topical product also offered significant improvements in skin radiance (P=0.0015) and skin texture (P=0.0058), which the hydroquinone 4% cohort did not demonstrate. The hydroquinone 4% cohort experienced 5 adverse events, while there were no adverse events associated with the novel topical product. Subjects in the hydroquinone 4% cohort also more frequently experienced burning/stinging, tingling, itching, erythema, and dryness., Conclusion: A novel topical product with PATH-3 Technology, designed to counteract various steps in pigmentation pathways, has been demonstrated to be safe and effective in treating facial dyschromia., Citation: Wang JV, Fabi SG, Mraz Robinson D, et al. A multi-center, randomized, blinded clinical study evaluating the efficacy and safety of a novel topical product for facial dyschromia. J Drugs Dermatol. 2023;22(4):333-338. doi:10.36849/JDD.7340.

We read with great interest the recent publication by F&ouml;lster-Holst et al1 in the May issue of Journal of Drugs in Dermatology, which offered a brief update on the treatment of port-wine stains.

Background: Primary malignancies arising in the external auditory canal (EAC) are rare and usually are treated surgically. We review techniques to reconstruct the EAC following ablative surgery, and introduce a rarely utilized tragal skin flap which has particular advantages for reconstruction of limited anterior EAC defects., Methods: The terms "tragal flap", "external auditory canal", "preauricular tragal flap", "reconstructive techniques" were searched on PubMed and Google Scholar., Results: Our review identified one description of a tragal flap to reconstruct the EAC following resection of a malignancy. We add an additional case of a preauricular tragal flap to reconstruct the anterior EAC following resection of a recurrent basal cell carcinoma located in the EAC that led to a circumferential defect., Conclusion: There are several surgical techniques that can be utilized to reconstruct the EAC. We describe a novel tragal flap used to reconstruct the anterior EAC following resection of a recurrent tumor., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Importance: Sturge-Weber syndrome (SWS) is a neurocutaneous syndrome involving the skin, brain, and eyes. Consensus recommendations for management are lacking., Objective: To consolidate the current literature with expert opinion to make recommendations that will guide treatment and referral for patients with port-wine birthmarks (PWBs)., Evidence Review: In this consensus statement, 12 nationally peer-recognized experts in dermatology with experience treating patients with SWS were assembled. Key topics and questions were formulated for each group and included risk stratification, optimum treatment strategies, and recommendations regarding light-based therapies. A systematic PubMed search was performed of English-language articles published between December 1, 2008, and December 1, 2018, as well as other pertinent studies identified by the expert panel. Clinical practice guidelines were recommended., Findings: Treatment of PWBs is indicated to minimize the psychosocial impact and diminish nodularity and potentially tissue hypertrophy. Better outcomes may be attained if treatments are started at an earlier age. In the US, pulsed dye laser is the standard for all PWBs regardless of the lesion size, location, or color. When performed by experienced physicians, laser treatment can be safe for patients of all ages. The choice of using general anesthesia in young patients is a complex decision that must be considered on a case-by-case basis., Conclusions and Relevance: These recommendations are intended to help guide clinical practice and decision-making for patients with SWS and those with isolated PWBs and may improve patient outcomes.

Background and Objectives: Post inflammatory hyperpigmentation (PIH) can be difficult to treat especially in patients with darker skin types as darker skin carries increased epidermal melanin content. Various treatments available to improve the appearance of PIH may incite further pigmentation thus making treatment extremely difficult and frustrating. The purpose of this study was to perform a retrospective chart and photographic review to evaluate the efficacy and safety profile of a low energy low density non-ablative fractional1927 nm wavelength laser treatment for PIH in patients with Fitzpatrick skin types IV-VI., Study Design: A retrospective evaluation of 61 patients with PIH treated with a 1927 nm laser was conducted at a single center. Inclusion criteria required at least 2 treatment sessions so that before and after treatment photographs would be available for comparison and study purposes. Two blinded physician-evaluators using a visual analog scale for percentage of pigmentary clearance in standard photographs assessed treatment efficacy., Results: The mean percent improvement after treatment, evaluated by two dermatologists was 43.24%. The correlation between raters was statistically significant (Pearson's correlation coefficienct of r = 0.59, p < 0.0001). No side effects were observed in the patients treated with the 1927 nm laser., Conclusion: The low energy low density non-ablative fractional 1927 nm wavelength laser is a safe and effective modality for improving post inflammatory hyperpigmentation in patients with darker skin types. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc., (© 2019 Wiley Periodicals, Inc.)

Background: Multiple exposures to general anesthesia may be neurotoxic to the developing brain. This relationship has not been evaluated in children undergoing laser surgery for vascular anomalies., Objective: To evaluate the prevalence of neurodevelopmental abnormalities in children who received multiple laser procedures under general anesthesia before the age of 4 years for the treatment of vascular anomalies., Methods and Materials: Retrospective chart review of patients with contact of parents for telephone interview., Results: Thirty-three patients were eligible. Average age at the time of survey was 7.8 years. Twenty-three (84.8%) patients were female, with average age at the time of first treatment at 1.9 years. Average number of treatments received before the age of 4 years was 6.7. Anesthetics included inhalational nitrous oxide and isoflurane and intravenous propofol. Seven patients carried one or more of the following diagnoses: attention-deficit hyperactivity disorder (3.0%), anxiety (6.1%), behavioral disorder (3.0%), language disorder (3.0%), speech disorder (3.0%), and motor disorder (6.1%). These prevalence rates are similar to those found in the US population., Conclusion: This is the first report on the prevalence of neurodevelopmental disorders in children undergoing multiple laser treatments under general anesthesia. Although the study sample is small, no increased risks when comparing with prevalence rates reported in the literature were noted.

Background & Objective: Surgical scars are an unwanted sequela following surgical procedures. Several different treatment modalities and approaches are currently being employed to improve the cosmesis of surgical scars with each having varying degrees of success. The objective of this study was to assess the ef cacy and safety pulsed dye laser treatment, CO2 ablative fractional resurfacing, and a combined treatment with these two modalities for the cosmetic improvement of surgical scarring that occurred following the surgical removal of skin cancer from different anatomic areas., Materials and Methods: Twenty-five patients with surgical scarring most frequently on the face following recent surgical excision of skin cancer with Mohs surgery were included in this multicenter, prospective clinical study. Patients were randomized into 4 treatment arms, namely, pulsed dye laser alone, CO2 laser alone, a combined treatment with these two modalities, and CO2 ablative fractional resurfacing on the same day of surgery to half of the scar, followed by a combined treatment with the two modalities to that half of the scar. Patients in each study arm received a total of 3-4 treatments, while those patients in Arm 4 underwent an additional treatment with CO2 laser immediately after surgery. Patients were followed up at 1 and 3 months after the final treatment session., Results: No adverse events were seen. Significant improvements in the appearance of scars were achieved in all study arms, as as- sessed by the Vancouver Scar Scale and Global Evaluation Response scales, with the best clinical outcomes seen in those scars that underwent a combination treatment. All patients reported very high satisfaction from treatment., Conclusion: Both pulsed dye laser treatment and CO2 ablative fractional resurfacing, when used as a monotherapy, are safe and effective in the treatment and improvement of recent surgical scarring. When both of these modalities are used in combination, however, they appear to potentially have a synergistic effect and an accelerated outcome on the cosmesis of recent surgical scars. J Drugs Dermatol. 2016;15(11):1315-1319..

Background and Objectives: Tattoo removal can inadvertently lead to paradoxical darkening after laser procedure. We present a new laser device that may treat this unwanted outcome., Study Design/patients and Methods: We report two cases from a clinical trial, using a novel picosecond 532 nm and 1,064 nm laser to treat unwanted red tattoos., Results: Two cases of paradoxical darkening improved with the use of a novel picosecond 532 nm and 1,064 nm laser., Conclusion: The use of a picosecond 532 nm and 1,064 nm laser may treat paradoxical darkening in red colored tattoos. Lasers Surg. Med. 48:471-473, 2016. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Background: Photodamaged facial skin is characterized by fine lines and wrinkles, mottled pigmentation, and other changes., Objective: To evaluate and compare the efficacy and tolerance of a home-use laser device when used alone or in combination with an antioxidant facial treatment for moderate photodamage., Methods: This was a 49-subject, evaluator-blinded, split-face, randomized, single-center, 24-week, phase-2, study. In phase 1, all subjects were treated on one facial side with test products and a home-use laser device and the other side was treated with laser alone for 12 weeks, followed by a 2-week regression period during which they used only support materials. For phase 2, all subjects were divided into 2 independent treatment groups. For the next 10 weeks, subjects of first group treated the assigned facial side with test products and support materials and the other facial side with only support materials. Subjects in the second group treated their entire face with only support materials. Efficacy and tolerance were assessed by clinical grading, VISIA-CR imaging, and self-assessment questionnaires., Results: The combination of laser and test products improved all photodamage parameters evaluated., Conclusion: The test products enhanced and prolonged clinical benefits obtained with the laser alone.

Novel strategies are urgently needed to address the millions of nonmelanoma skin cancers treated in the United States annually. The need is greatest for those patients who are poor surgical candidates or those prone to numerous nonmelanoma skin cancers and therefore at risk for marked disfigurement. Traditional treatment strategies include electrosurgery with curettage, radiation therapy, cryotherapy, excision, and Mohs micrographic surgery. Alternatives to traditional treatment, including topical medications and light or laser therapies, are becoming popular; however, there are various degrees of efficacy among these alternative tactics. These alternatives include topical retinoids, peels, 5-fluorouracil, imiquimod, photodynamic therapy, and lasers. The purpose of this paper is to review the available data regarding these alternative strategies and permit the reader to have a sense of which therapies are reasonable options for care., (2011 Elsevier Inc. All rights reserved.)

Background: The use of light-emitting diode light offers practical advantages in photodynamic therapy (PDT) with topical methyl-aminolevulinate (MAL) for management of actinic keratoses (AK)., Objective: We sought to evaluate the efficacy of MAL PDT using red light-emitting diode light., Methods: We conducted a multicenter, double-blind, randomized study. A total of 49 patients with 363 AK lesions had 16.8% MAL cream applied under occlusion for 3 hours, and 47 patients with 360 AK lesions had vehicle cream similarly applied. The lesions were then illuminated (630 nm, light dose 37 J/cm2) with repeated treatment 1 week later. Complete lesion and patient (all lesions showing complete response) response rates were evaluated 3 months after last treatment., Results: MAL PDT was superior (P<.0001) to vehicle PDT with respect to lesion complete response (86.2% vs 52.2%, odds ratio 6.9 [95% confidence interval 4.7-10.3]) and patient complete response (59.2% vs 14.9%, odds ratio 13.2 [95% confidence interval 4.1-43.1])., Limitations: The study population may not be representative of all patients with AK., Conclusion: MAL PDT using red light-emitting diode light is an appropriate treatment alternative for multiple AK lesions.

The Dialysis Patients Response to IV Iron with Elevated Ferritin (DRIVE) study demonstrated the efficacy of intravenous ferric gluconate to improve hemoglobin levels in anemic hemodialysis patients who were receiving adequate epoetin doses and who had ferritin levels between 500 and 1200 ng/ml and transferrin saturation (TSAT) < or = 25%. The DRIVE-II study reported here was a 6-wk observational extension designed to investigate how ferric gluconate impacted epoetin dosage after DRIVE. During DRIVE-II, treating nephrologists and anemia managers adjusted doses of epoetin and intravenous iron as clinically indicated. By the end of observation, patients in the ferric gluconate group required significantly less epoetin than their DRIVE dose (mean change of -7527 +/- 18,021 IU/wk, P = 0.003), whereas the epoetin dose essentially did not change for patients in the control group (mean change of 649 +/- 19,987 IU/wk, P = 0.809). Mean hemoglobin, TSAT, and serum ferritin levels remained higher in the ferric gluconate group than in the control group (P = 0.062, P < 0.001, and P = 0.014, respectively). Over the entire 12-wk study period (DRIVE plus DRIVE-II), the control group experienced significantly more serious adverse events than the ferric gluconate group (incidence rate ratio = 1.73, P = 0.041). In conclusion, ferric gluconate maintains hemoglobin and allows lower epoetin doses in anemic hemodialysis patients with low TSAT and ferritin levels up to 1200 ng/ml.