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.
BACKGROUND
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).


OBJECTIVE
To evaluate the efficacy, tolerability and safety of BVF treatment in patients with mild-to-moderate AA.


METHODS
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.


RESULTS
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%).


RESULTS
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 (P < 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 (P < 0.03). No serious adverse events were observed in both groups during the study.


CONCLUSIONS
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.
Mancuso
Giuseppe
G
Dermatologic Services of Lugo di Romagna, Bagnacavallo, Alfonsine and Russi, Ravenna, Italy.
Balducci
Antonella
A
Casadio
Chiara
C
Farina
Paolo
P
Staffa
Mauro
M
Valenti
Lorenzo
L
Milani
Massimo
M
D000287:Administration, Topical; D000328:Adult; D000506:Alopecia Areata / Q000188:drug therapy*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D001623:Betamethasone / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D001624:Betamethasone Valerate / Q000008:administration & dosage*; D004304:Dosage Forms; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016037:Single-Blind Method; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D004304:Dosage Forms; C011175:betamethasone-17,21-dipropionate; D001623:Betamethasone; D001624:Betamethasone Valerate