Efficacy of betamethasone valerate foam formulation in comparison with betamethasone dipropionate lotion in the treatment of mild‐to‐moderate alopecia areata: A multicenter, prospective, randomized, controlled, investigator‐blinded trial

<jats:title>Abstract</jats:title><jats:p><jats:bold>Background</jats:bold> Betamethasone valerate foam (BVF) is a new topical corticosteroid formulation. In scalp psoriasis patients BVF has induced a significantly greater clinical improvement in comparison with corticosteroid lotions. No data are available to date regarding the efficacy and safety of BVF in mild‐to‐moderate alopecia areata (AA).</jats:p><jats:p><jats:bold>Study aim</jats:bold> To evaluate the efficacy, tolerability and safety of BVF treatment in patients with mild‐to‐moderate AA.</jats:p><jats:p><jats:bold>Subjects and Methods</jats:bold> Sixty‐one patients (26 men and 35 women; mean age 41 ± 13 years) with mild‐to‐moderate AA (hair loss < 26%) were enrolled in a parallel‐group, investigator‐blinded trial. Subjects were assigned randomly to BVF (31 patients) or to betamethasone dipropionate lotion (BDL) (30 subjects). Both treatments were applied to the affected areas twice a day for 12 consecutive weeks.</jats:p><jats:p><jats:bold>Outcomes</jats:bold> The primary study outcome was to compare the hair regrowth rate. Efficacy was evaluated at weeks 8 and 12 and at follow up (week 20), using a hair regrowth score (RGS) with a scale ranging from 0 (regrowth < 10%) to 4 (regrowth > 75%).</jats:p><jats:p><jats:bold>Results</jats:bold> Fifty‐seven subjects (93%) completed the trial. At week 20, the RGS was 3.1 ± 1.5 and 1.8 ± 1.6 in the BVF and BDL groups, respectively (<jats:italic>P</jats:italic> < 0.01). A RGS > 3 was observed in 61% of patients in the BVF group (19/31) in comparison with 27% (8/30) in the BDL group (<jats:italic>P</jats:italic> < 0.03). No serious adverse events were observed in both groups during the study.</jats:p><jats:p><jats:bold>Conclusion</jats:bold> Betamethasone valerate foam has shown to be an effective and well‐tolerated treatment of mild‐to‐moderate AA. Further trials are warranted to evaluate the role of this new formulation in comparison or in combination with intralesional corticosterioids in AA treatment.</jats:p>