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

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.