Oral isotretinoin combined with topical clobetasol 0.05% and tacrolimus 0.1% for the treatment of frontal fibrosing alopecia: a randomized controlled trial.

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.