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Guidelines for clinical trials of frontal fibrosing alopecia: consensus recommendations from the International FFA Cooperative Group (IFFACG)

Olsen, E A; Harries, M; Tosti, A; Bergfeld, W; Blume-Peytavi, U; Callender, V; Chasapi, V; Correia, O; Cotsarelis, G; Dhurat, R; Dlova, N; Doche, I; Enechukwu, N; Grimalt, R; Itami, S; Hordinsky, M; Khobzei, K; Lee, W-S; Malakar, S; Messenger, A; McMichael, A; Mirmirani, P; Ovcharenko, Y; Papanikou, S; Pinto, G M; Piraccini, B M; Pirmez, R; Reygagne, P; Roberts, J; Rudnicka, L; Saceda-Corralo, D; Shapiro, J; Silyuk, T; Sinclair, R; Soares, R O; Souissi, A; Vogt, A; Washenik, K; Zlotogorski, A; Canfield, D; Vano-Galvan, S
BACKGROUND:Frontal fibrosing alopecia (FFA) has become one of the most common causes of cicatricial alopecia worldwide. However, there is a lack of clear aetiology and robust clinical trial evidence for the efficacy and safety of agents currently used for treatment. OBJECTIVES/OBJECTIVE:To enable data to be collected worldwide on FFA using common criteria and assessment methods. METHODS:A multicentre, international group of experts in hair loss was convened by email to create consensus recommendations for clinical trials. Consensus was defined at > 90% agreement on each recommended part of these guidelines. RESULTS:Standardized diagnostic criteria, severity rating, staging, and investigator and patient assessment of scalp hair loss and other clinical features of FFA were created. CONCLUSIONS:These guidelines should allow the collection of reliable aggregate data on FFA and advance efforts in both clinical and basic research to close knowledge gaps in this condition.
PMID: 34105768
ISSN: 1365-2133
CID: 5003652

Racial Variations in COVID-19 Deaths May Be Due to Androgen Receptor Genetic Variants Associated with Prostate Cancer and Androgenetic Alopecia. Are Anti-Androgens a Potential Treatment for COVID-19? [Letter]

McCoy, John; Wambier, Carlos G; Vano-Galvan, Sergio; Shapiro, Jerry; Sinclair, Rodney; Müller Ramos, Paulo; Washenik, Kenneth; Andrade, Murilo; Herrera, Sabina; Goren, Andy
Racial disparities in COVID-19 infection rates and disease severity are due to a multifactorial etiology that can include socioeconomic as well as other factors. Nevertheless, genetic factors in different ethnic groups often contribute to disease severity and treatment response. In particular, the frequency of genetic variations in the androgen receptor differs by ethnicity and gender. For example, the increased prevalence of prostate cancer and androgenetic alopecia among African Americans correlates with the frequency of these variants. In this communication, we propose that androgens may be implicated in COVID-19 disease severity. As such, special attention may need to be given to African Americans infected by the SARS-CoV-2 virus. Finally, if a link to genetic variations in the androgen receptor and COVID-19 disease severity can be established, it would suggest new treatment options.
PMID: 32333494
ISSN: 1473-2165
CID: 4402582


Goren, A; Mc Coy, J; Wambier, C G; Vano-Galvan, S; Shapiro, J; Dhurat, R; Washenik, K; Lotti, T
PMID: 32237190
ISSN: 1529-8019
CID: 4371512

A Phase III, Multicenter, Parallel-Design Clinical Trial to Compare the Efficacy and Safety of 5% Minoxidil Foam Versus Vehicle in Women With Female Pattern Hair Loss

Bergfeld, Wilma; Washenik, Ken; Callender, Valerie; Zhang, Paul; Quiza, Carlos; Doshi, Uday; Blume-Peytavi, Ulrike
BACKGROUND Female pattern hair loss (FPHL) is a common hair disorder that affects millions of women. A new 5% minoxidil topical foam (MTF) formulation, which does not contain propylene glycol, has been developed
OBJECTIVE: To compare the efficacy and safety of once-daily 5% MTF with vehicle foam for the treatment of FPHL
MATERIALS AND METHODS: This was a Phase III, randomized, double-blind, vehicle-controlled, parallel-group, international multicenter trial (17 sites) in women aged at least 18 years with FPHL (grade D3 to D6 on the Savin Density Scale), treated once daily with 5% MTF or vehicle foam for 24 weeks. The co-primary efficacy endpoints were the change from baseline at week 24 in target area hair count (TAHC) and subject assessment of scalp coverage. Also evaluated were TAHC at week 12, expert panel review of hair regrowth at week 24, and change from baseline in total unit area density (TUAD, sum of hair diameters/cm2) at weeks 12 and 24
RESULTS: A total of 404 women were enrolled. At 12 and 24 weeks, 5% MTF treatment resulted in regrowth of 10.9 hairs/cm2 and 9.1 hairs/cm2 more than vehicle foam, respectively (both P<.0001). Improved scalp coverage at week 24 was observed by both subject self-assessment (0.69-point improvement over vehicle foam; P<.0001) and expert panel review (0.36-point improvement over the vehicle foam; P<.0001). TUAD increased by 658 μm/cm2 and 644 μm/cm2 more with 5% MTF than with vehicle foam at weeks 12 and 24, respectively (both P<.0001). MTF was well tolerated. A low incidence of scalp irritation and facial hypertrichosis was observed, with no clinically significant differences between groups
CONCLUSION: Five percent MTF once daily for 24 weeks was well tolerated and promoted hair regrowth in women with FPHL, resulting in improved scalp coverage and increased hair density compared with vehicle foam. identifier: nCT01226459

J Drugs Dermatol 2016;15(7):874-881.
PMID: 27391639
ISSN: 1545-9616
CID: 2332272

Future horizons in hair restoration

Marshall, Bryan T; Ingraham, Chris A; Wu, Xunwei; Washenik, Ken
This article reviews the history of hair follicle regeneration from follicular fragments and dissociated cells. The challenges of trichogenic in vitro culture and subsequent delivery into the patient are discussed, as well as cosmetic acceptance, recent achievements on regeneration of human hair follicles, and new potential cell sources for hair regeneration.
PMID: 24017993
ISSN: 1064-7406
CID: 550062

Comparison of tazarotene and minocycline maintenance therapies in acne vulgaris: a multicenter, double-blind, randomized, parallel-group study

Leyden, James; Thiboutot, Diane M; Shalita, Alan R; Webster, Guy; Washenik, Kenneth; Strober, Bruce E; Shupack, Jerome
OBJECTIVE: To evaluate the efficacy of 3 maintenance regimens (topical tazarotene, oral minocycline hydrochloride, or both) in sustaining improvement in acne. DESIGN: Multicenter, open-label treatment phase followed by double-blind, randomized, parallel-group maintenance phase. SETTING: Ambulatory patients in research or referral centers. PATIENTS: Volunteer sample of 189 patients with moderately severe to severe acne vulgaris (110 entered maintenance phase, 90 completed, and 2 discontinued because of adverse events). INTERVENTIONS: All patients were treated with 0.1% tazarotene gel (each evening) and a 100-mg capsule (twice daily) of minocycline hydrochloride for up to 12 weeks. Patients with 75% or greater global improvement at week 12 were randomly assigned to 12 weeks of maintenance therapy with tazarotene gel plus placebo capsules, vehicle gel plus minocycline capsules, or tazarotene gel plus minocycline capsules. MAIN OUTCOME MEASURES: Overall disease severity, global improvement, and lesion counts. RESULTS: All regimens were effective in sustaining improvements in acne. After 12 weeks of maintenance therapy, the mean reductions from baseline in noninflammatory and inflammatory lesion count, respectively, were 60% and 54% with tazarotene, 52% and 66% with minocycline, and 64% and 66% with tazarotene plus minocycline. At week 24, more than 80% of patients in each group had maintained a 50% or greater global improvement from baseline, and more than 50% had maintained a 75% or greater global improvement. CONCLUSIONS: A high percentage of patients with moderately severe to severe acne can maintain improvement in their condition with topical retinoid monotherapy. Maintenance with combination tazarotene and minocycline therapy showed a trend for greater efficacy but no statistical significance vs tazarotene alone. Topical retinoid monotherapy should be considered for maintenance to help minimize antibiotic exposure
PMID: 16702498
ISSN: 0003-987x
CID: 94895

Etanercept does not effectively treat moderate to severe alopecia areata: an open label study [Meeting Abstract]

Strober, BE; Siu, K; Alexis, AF; Kim, G; Washenik, K; Sinha, A; Shupack, JL
ISSN: 0022-202x
CID: 104636

Etanercept does not effectively treat moderate to severe alopecia areata: an open-label study

Strober, Bruce E; Siu, Kimberly; Alexis, Andrew F; Kim, Gene; Washenik, Ken; Sinha, Animesh; Shupack, Jerome L
In this prospective, open-label pilot study, we evaluated the safety and efficacy of etanercept, a TNF-alpha inhibitor, in the treatment of moderate to severe alopecia areata, alopecia totalis, or alopecia universalis. Seventeen otherwise healthy adults with moderate to severe alopecia areata were enrolled. The primary outcome measure was the extent of hair regrowth during and after the end of treatment as evaluated by the Severity of Alopecia Tool (the SALT score). After between 8 and 24 weeks of continuous treatment with etanercept 50 mg given subcutaneously twice weekly, significant regrowth of hair was not shown in any of the subjects treated. Based on these results, etanercept appears to be ineffective in treating subjects with treatment-refractory, moderate to severe alopecia areata, alopecia totalis, or alopecia universalis
PMID: 15928633
ISSN: 1097-6787
CID: 56160

Topical retinoids in inflammatory acne: A retrospective, investigator-blinded, vehicle-controlled, photographic assessment [Meeting Abstract]

Leyden, JJ; Shalita, A; Thiboutot, D; Washenik, K; Webster, G
Background: Despite published data showing the efficacy of topical retinoids in treating inflammatory acne, in clinical practice topical retinoids tend to be used most commonly for noninflammatory acne. Objective: The goal of this study was to assess the efficacy of topical retinoids as monotherapy in inflammatory acne. Methods: This retrospective, Investigator-blinded, vehicle-controlled, photographic assessment study was conducted by 5 investigators. The investigators rated pretreatment and posttreatment photographs of patients who had participated in 12- or 15-week, double-blind comparisons of tazarotene 0.1% gel, adapalene 0.1% gel, tretinoin 0.1% microsponge, tretinoin 0.025% gel, and tazarotene 0.1% cream (vehicle). Acne severity was rated on a 7-point scale. A posttreatment increase or decrease of 1 grade was considered clinically meaningful; >= 2 grades was considered an even clearer measure of clinically significant improvement. Investigators also rated global response to treatment on a 7-point scale. A posttreatment increase of >= 2 grades was considered a clinically relevant improvement. Results: Each of the 5 investigators rated photographs of 577 patients (similar to 52% women, similar to 48% men; mean age, 18-20 years), for a total of 2885 evaluations (in addition to daily evaluations of the 20 control patients). The treatment groups consisted of tazarotene (252 patients, 1260 evaluations), adapalene (178 patients, 890 evaluations), tretinoin microsponge (47 patients, 235 evaluations), tretinoin gel (39 patients, 195 evaluations), and vehicle (61 patients, 305 evaluations). Inflammatory acne was improved with all 4 retinoids compared with vehicle. In 1905 evaluations in which pretreatment acne severity was grade 3 (mild to moderate), the incidences of clinically significant improvements In the tazarotene, adapalene, and tretinoin microsponge groups were 24%, 17%, and 21%, respectively (all, P <= 0.001 vs vehicle [7%]). The difference in prevalence of clinically significant improvement was statistically similar between the tretinoin gel and vehicle groups. The incidences of clinically relevant improvement in global response to tazarotene, adapalene, tretinoin microsponge, and tretinoin gel were 36%, 34%, 31%, and 28%, respectively (P <= 0.001, <= 0.001, <= 0.001, and <= 0.01, respectively, vs vehicle [17%]). Conclusions: The results of this study suggest that topical retinoid monotherapy can achieve clinically significant improvements in inflammatory acne.
ISSN: 0149-2918
CID: 50164

Evaluation and treatment of male and female pattern hair loss

Olsen, Elise A; Messenger, Andrew G; Shapiro, Jerry; Bergfeld, Wilma F; Hordinsky, Maria K; Roberts, Janet L; Stough, Dow; Washenik, Ken; Whiting, David A
PMID: 15692478
ISSN: 1097-6787
CID: 67509