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Background: Crisaborole is a nonsteroidal anti-inflammatory phosphodiesterase 4 inhibitor that is approved for the treatment of patients with mild-to-moderate atopic dermatitis (AD); however, the efficacy and safety of crisaborole in patients with AD and other atopic comorbidities have not been investigated. Objective: This post hoc pooled analysis of the pivotal phase III studies (CrisADe CORE 1 and CORE 2) assessed the efficacy and safety of crisaborole versus vehicle in patients aged ≥ 2 years with mild-to-moderate AD and other atopic comorbidities. Methods: Patients with mild-to-moderate AD and a medical history of asthma, allergic rhinitis, or food allergies were identified. Efficacy assessments included the proportion of patients who achieved Investigator's Static Global Assessment (ISGA) success at day 29, ISGA clear or almost clear at day 29, and improvement in the Severity of Pruritus Scale score at week 4. Safety was assessed via treatment-emergent adverse events (TEAEs). Results: This analysis included 1522 patients (crisaborole, 1016; vehicle, 506); 26.2, 15.9, and 16.5% had a medical history of asthma, allergic rhinitis, and food allergies, respectively. The mean age was 12.2 years. A significantly greater proportion of patients treated with crisaborole achieved ISGA success at day 29 compared with patients treated with vehicle for most subgroups analyzed. Furthermore, a significantly greater proportion of patients treated with crisaborole achieved ISGA clear or almost clear at day 29 across all subgroups and demonstrated improvement in the Severity of Pruritus Scale score at week 4 versus patients treated with vehicle in most of the subgroups. Overall, most TEAEs were mild or moderate in severity; the most common treatment-related TEAE in patients with atopic comorbidities was application-site pain (crisaborole, 5.1%; vehicle, 1.7%). Conclusion: Crisaborole was efficacious and well tolerated in patients with mild-to-moderate AD and other atopic comorbidities, which suggested that crisaborole should be considered for the management of AD in this population. Clinical Trials NCT02118766 (CrisADe CORE 1) and NCT02118792 (CrisADe CORE 2), www.clinicaltrials.gov.

Background: Actinic keratoses (AKs) are common premalignant skin lesions triggered by excessive ultraviolet exposure. The majority of AKs regress or persist, but some progress to squamous cell carcinomas. Biomarkers associated with their persistence, progression and regression have not been characterized., Objectives: We performed skin biopsies in patients with extensive actinic damage to identify biomarkers that correlate with clinical progression and regression of AKs., Methods: This was an observational study of a cohort of patients with extensive actinic damage. AKs were mapped on a clear plastic template in 26 patients at months 3, 6, 9 and 11. Biopsies were taken from randomly selected, predetermined AKs and were evaluated for p53, E-cadherin, Snail, Slug and Twist. The study is registered at Clinicaltrials.gov: NCT00027976., Results: p53 exhibited greater expression in clinically apparent AKs (histological score 2·89 ± 1·45) than in regressed AKs (0·75 ± 0·96); P < 0·01. There was also significantly less membrane E-cadherin, the lack of which is a marker of epithelial-mesenchymal transition, in clinically apparent AKs (1·89 ± 1·81) than in sun-exposed skin (3·07 ± 1·75); P < 0·005. The E-cadherin transcription repressors Snail, Slug and Twist were increased in AKs compared with sun-exposed skin. A limitation of the study is that measurement of histological biomarkers was not a primary end point. In addition, patients were allowed to apply sunscreens., Conclusions: At the molecular level, loss of E-cadherin and an increase in p53 are linked to the dynamic interplay between the persistence, progression and regression of AKs. What's already known about this topic? Actinic keratoses (AKs) are common dysplastic epidermal lesions that result from chronic and excessive ultraviolet exposure. Biomarkers associated with progression and regression of AK have not been characterized. What does this study add? Decreased E-cadherin and increased p53, Snail, Slug and Twist (E-cadherin transcription factors) were associated with progression from AK to nonmelanoma skin cancer. What is the translational message? Strategies targeting these molecules may be effective in reversing rising skin cancer rates. E-cadherin, p53, Snail, Slug and Twist are potential biomarkers that may be used to assess the efficacy of existing chemopreventive agents., (© 2019 British Association of Dermatologists.)

Background: Topical efinaconazole 10% solution is a promising new treatment for distal lateral subungual onychomycosis (DLSO). However, it is unknown whether this treatment is both compatible and efficacious in individuals wearing toenail polish., Materials and Methods: We evaluated the efficacy and compatibility of efinaconazole 10% solution with concurrent nail polish use in treating DLSO over 52 weeks. Efficacy was assessed using the onychomycosis severity index (OSI) and by measuring nail growth and thickness, while compatibility with nail polish was evaluated with questionnaires., Results: Eleven patients completed the study; 6 wore nail polish regularly and 5 abstained from polish. The efficacy of efinaconazole was not diminished by concurrent nail polish use as measured by OSI, nail growth, and thickness. However, this treatment produced undesirable cosmetic changes to the quality of nail polish over time., Conclusions: While efinaconazole 10% solution is an effective treatment of DLSO in patients wearing nail polish, this treatment may diminish the quality of the polish. Further research and development is needed to enhance the compatibility of topical onychomycosis treatments with nail polish use.

Local adverse reactions to vaccination are typically mild and often quickly resolve. Vaccine adjuvants such as aluminum salts in combination with improper vaccination technique may result in severe local adverse reactions. As far as we know, there is only one prior case of frankly necrotic rapidly progressing vaccine site necrosis, which occurred in a pediatric patient.1 To our knowledge, this is the first adult case of vaccine site necrosis to be reported. The presumed etiology has been aluminum salt adjuvants and improper vaccination technique. Here we present an adult case of a severe local reaction to a vaccine resulting in necrosis of the epidermis and dermis with central ulceration. Skin appendages were also involved, with necrosis of eccrine coils and hair follicles. This necrotic ulceration was likely due to robust inflammatory response to aluminum salt subcutaneous injection. Correct vaccine placement, needle size, and needle length may reduce adverse local skin reactions.

J Drugs Dermatol. 2018;17(3):364-367.

This column describes the development, implementation, and outcomes of a quality improvement learning collaborative that aimed to better integrate chaplaincy with mental health care services at 14 participating health care facilities evenly distributed across the U.S. Department of Veterans Affairs and Department of Defense. Teams of health care chaplains and mental health professionals from participating sites sought to improve cross-disciplinary service integration in six key domains: screening, referrals, assessment, communication and documentation, cross-disciplinary training, and role clarification. Chaplains and mental health providers across all facilities at participating sites were significantly more likely post-collaboration to report having a clear understanding of how to collaborate and to report using a routine process for screening patients who could benefit from seeing a professional from the other discipline. Foundational efforts to enhance cross-disciplinary awareness and screening practices between chaplains and mental health professionals appear particularly promising.

Chaplains play an important role in supporting the mental health of current and former military personnel; in this study, the engagement of Department of Veterans Affairs (VA), Army, Navy, and Air Force chaplains with suicidality among their service users were examined. An online survey was used to collect data from 440 VA and 1,723 Department of Defense (DoD) chaplains as part of the VA/DoD Integrated Mental Health Strategy. Differences were noted for demographics, work setting characteristics, encountering suicidality, and self-perceived preparation for dealing with suicidality. Compared to DoD chaplains, VA chaplains encounter more at-risk service users, yet feel less prepared for dealing with suicidality., (Published 2015. This article is a U.S. Government work and is in the public domain in the USA.)

The Warrior to Soul Mate (W2SM) program is a grassroots initiative on the part of Veterans Affairs chaplain services to provide relationship enhancement skills to veterans and significant others based on the Practical Application of Intimate Relationship Skills model. To examine the implementation and sustainability of the W2SM program, two online surveys were sent to each participating facility's W2SM leader. The first examined how individual W2SM events were conducted (100% response rate, 67 surveys) and the second assessed facility-level issues impacting program sustainability (100% response rate, 23 surveys). Four sites were selected for qualitative interviews based on levels of sustainability. In 2013, W2SM served 1,664 people including 847 veterans, incurring reasonable program costs when compared to other intensive Veterans Affairs services. However, there have been important systematic (e.g., contracting processes) and resource (e.g., time, concern over funding) challenges that are reflected in the wide range of predicted program sustainability., (Reprint & Copyright © 2015 Association of Military Surgeons of the U.S.)

Background: Recognizing that clergy and spiritual care providers are a key part of mental health care systems, the Department of Veterans Affairs (VA) and Department of Defense (DoD) jointly examined chaplains' current and potential roles in caring for veterans and service members with mental health needs., Objective: Our aim was to evaluate the intersection of chaplain and mental health care practices in VA and DoD in order to determine if improvement is needed, and if so, to develop actionable recommendations as indicated by evaluation findings., Design: A 38-member multidisciplinary task group partnered with researchers in designing, implementing, and interpreting a mixed methods study that included: 1) a quantitative survey of VA and DoD chaplains; and 2) qualitative interviews with mental health providers and chaplains., Participants: Quantitative: the survey included all full-time VA chaplains and all active duty military chaplains (n = 2,163 completed of 3,464 invited; 62 % response rate). Qualitative: a total of 291 interviews were conducted with mental health providers and chaplains during site visits to 33 VA and DoD facilities., Main Measures: Quantitative: the online survey assessed intersections between chaplaincy and mental health care and took an average of 37 min to complete. Qualitative: the interviews assessed current integration of mental health and chaplain services and took an average of 1 h to complete., Key Results: When included on interdisciplinary mental health care teams, chaplains feel understood and valued (82.8-100 % of chaplains indicated this, depending on the team). However, findings from the survey and site visits suggest that integration of services is often lacking and can be improved., Conclusions: Closely coordinating with a multidisciplinary task group in conducting a mixed method evaluation of chaplain-mental health integration in VA and DoD helped to ensure that researchers assessed relevant domains and that findings could be rapidly translated into actionable recommendations.

Background: Pityriasis (tinea) versicolor is a superficial fungal infection of the stratum corneum caused by Malassezia species. The diagnosis is made clinically by its classic appearance of round or oval macules with fine scale that may be hyperpigmented or hypopigmented. Diagnosis may also be confirmed with microscopic evaluation of skin scrapings that reveal both short, stubby hyphae, and spores under KOH preparation. Ketoconazole is an important treatment of pityriasis versicolor but is primarily used in cream formulas. A foam vehicle has been shown to improve drug absorption through the stratum corneum and distribution in the skin. This study has assessed the safety and efficacy of ketoconazole 2% foam in treatment of pityriasis versicolor., Methods: Ketoconazole 2% foam was evaluated in a single-center, open-label, one-arm pilot study which enrolled eleven subjects to gain 10 evaluable subjects aged 21 years and older with a clinical diagnosis of tinea versicolor and positive KOH using calcofluor. The subjects came for 4 scheduled visits (baseline, week 1, week 2, and week 4) and were instructed to apply ketoconazole 2% foam to all affected areas twice daily for 2 weeks. At each visit, mycological and clinical assessment of a target area was done, along with static global assessment and body surface area estimation of the disease in each subject. Patient questionnaires were given at baseline and at week 2 to rate pruritus and satisfaction with the foam., Results: At the week 2 visit, following the treatment period, three out of ten evaluable subjects had negative skin samples prepared with KOH/calcifluor. Of these three, one subject later showed recurrence of fungal elements consistent with tinea versicolor at the week 4 follow-up visit. The other negative subjects remained negative and four additional subjects tested negative at week 4. Three subjects with positive samples at week 4 had only yeast forms without hyphae present. Investigator ratings of the target area were averaged for each clinical feature and demonstrated improvement in scale, hyper- or hypopigmentation, erythema, and induration throughout the study. Average pruritus score increased slightly 1 week after the baseline visit, but then improved steadily over the remaining visits. The investigator's static global assessment rating showed improvement from mild to moderate disease at baseline to minimal or no disease at week 4 in 7 subjects. The remaining subjects showed neither improvement nor progression of the disease throughout the study. One out of the eleven subjects enrolled did not complete the study. One subject noted mild skin burning sensation after application of medicine. Post-treatment patient questionnaires indicated overall satisfaction with the foam vehicle., Limitations: This was a single-arm, open-label, noncomparative trial., Conclusion: Ketoconazole 2% foam improved overall clinical assessment and microscopic evidence of pityriasis versicolor in all subjects with favorable patient feedback regarding the novel foam vehicle.

Chaplains play important roles in caring for Veterans and Service members with mental health problems. As part of the Department of Veterans Affairs (VA) and Department of Defense (DoD) Integrated Mental Health Strategy, we used a sequential approach to examining intersections between chaplaincy and mental health by gathering and building upon: 1) input from key subject matter experts; 2) quantitative data from the VA / DoD Chaplain Survey (N = 2,163; response rate of 75% in VA and 60% in DoD); and 3) qualitative data from site visits to 33 VA and DoD facilities. Findings indicate that chaplains are extensively involved in caring for individuals with mental health problems, yet integration between mental health and chaplaincy is frequently limited due to difficulties between the disciplines in establishing familiarity and trust. We present recommendations for improving integration of services, and we suggest key domains for future research.

Objectives: To demonstrate the efficacy and evaluate the safety of sertaconazole nitrate cream 2% in the treatment of seborrheic dermatitis (SD)., Design: Single-center, open-label study., Setting: One academic medical center., Participants: Twenty adult male and female subjects aged 22 to 85 years (average, 56 years) with mild-to-severe seborrheic dermatitis of the face., Measurements: The primary efficacy evaluation was the proportion of subjects with a score of 0 or 1 at the end of treatment (week 4) on the Investigator's Static Global Assessment scale. Secondary end points included percent change from baseline to week 4 in sum individual scores of erythema, scaling, induration, and pruritus at a preselected target lesion. Other end points included change in scores on Subject's Global Assessment scale and the Dermatology Life Quality Index., Results: Success on the primary end point was achieved by 10 of 17 evaluable subjects (58.8%). Improvements in Investigator's Static Global Assessment score from baseline were statistically significant at each week. Significant improvements were also demonstrated in erythema, scaling, induration, and pruritus at week 4 compared to baseline. Improvement in Subject's Global Assessment scores compared to baseline were significant only at week 1 (P=0.031). Change in total mean SD Dermatology Life Quality Index scores from baseline to week 4 was 0.34 (± 0.62, P=0.039)., Conclusion: The results of this preliminary study support the efficacy and safety of sertaconazole nitrate cream, 2%, for the treatment of seborrheic dermatitis.

Trichophyton tonsurans is currently the leading cause of tinea capitis, but was only introduced into the United States less than six decades ago. In this study, we found a prevalence of 11% in Birmingham, Alabama, which is similar to earlier reports from other geographic regions. Despite previous reports concerning escalation, the prevalence appears to be stable over the past decade., (© 2011 Wiley Periodicals, Inc.)

Background: Acne, one of the most common skin diseases, is often mistakenly thought to affect exclusively the teenaged group. However, a significant number of patients either continue to experience acne or develop new-onset acne after the teenaged years., Objective: A survey was designed to assess the prevalence of acne in the teenaged years, and aged 20 to 29 years, 30 to 39 years, 40 to 49 years, and 50 years and older., Methods: Adults aged 20 years and older were asked to complete surveys distributed at various sites on our university campus and medical complex., Results: Of 1013 participants aged 20 years and older, 73.3% (n = 744) reported ever having acne. After the teenaged years, women were more likely to report having acne than men, with the difference being statistically significant in all age groups. The prevalence of acne reported in women versus men was as follows: 20 to 29 years, 50.9% (n = 276) versus 42.5% (n = 201) (P = .0073); 30 to 39 years, 35.2% (n = 152) versus 20.1% (n = 73) (P < .0001); 40 to 49 years, 26.3% (n = 93) versus 12.0% (n = 36) (P < .0001); and 50 years and older, 15.3% (n = 41) versus 7.3% (n = 18) (P = .0046)., Limitations: Our results are based on the participant's own perception of the presence or absence of acne rather than a clinical evaluation., Conclusions: Acne continues to be a common skin problem past the teenaged years, with women being affected at higher rates than men in all age groups 20 years or older.

Nail psoriasis can be debilitating and as therapeutic options are limited, it can be notoriously difficult to treat. As there are many new medications currently undergoing clinical trials in psoriasis, questions have arisen concerning the effectiveness of these new therapies with regard to psoriatic nail disease. We present the results of a prospective, open-label, proof of concept study to determine the efficacy and safety of alefacept in subjects with moderate to severe nail psoriasis.