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Oral Isotretinoin Combined With Topical Clobetasol 0.05% and Tacrolimus 0.1% for the Treatment of Frontal Fibrosing Alopecia: A Randomized Controlled Trial Publisher Pubmed



Mahmoudi H1 ; Rostami A1 ; Tavakolpour S1 ; Nili A1 ; Teimourpour A2 ; Salehi Farid A1 ; Abedini R1 ; Amini M1 ; Daneshpazhooh M1
Authors
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Authors Affiliations
  1. 1. Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran

Source: Journal of Dermatological Treatment Published:2022


Abstract

Background: Frontal fibrosing alopecia (FFA) is a scarring alopecia with no promising treatment. Objective: To evaluate the additive efficacy of oral isotretinoin to topical treatments. Methods: Between November 2017 and August 2018, FFA patients were randomly assigned to receive either isotretinoin (20 mg/d) plus topical treatments (clobetasol 0.05% and tacrolimus 0.1%) or monotherapy with topical treatments. Treatments’ efficacy was evaluated through Frontal Fibrosing Alopecia Severity Index (FFASI) after two and 6 months. Results: From 38 participants, 28 patients completed the study. Facial papules improved after 6 months (p value <.001) in the isotretinoin group. Moreover, frontotemporal hairline (p values for frontal <.001; R lateral: 0.03; L Lateral: 0.02), total scalp margins, total additional features’ scores, and total combined (p value <.001 for all) improved more in the isotretinoin group than in the control group. Frontal band improved in the treatment group (p value:.02). Frontal margin (p value:.01), R lateral (p value:.01), total scalp (p value <.01), and combined total scores (p value:.01) worsened in the control group. Isotretinoin-related side-effects included lip dryness, telogen effluvium, and malaise. Limitations: Small sample size and lost to follow-up. Conclusion: Isotretinoin combined with topical treatments is more effective than monotherapy with clobetasol and tacrolimus for FFA. Clinical Trial Code: (IRCT.ir) IRCT2017091736173N1. © 2020 Taylor & Francis Group, LLC.