Clobetasol propionate, 0.05%, vs hydrocortisone, 1%, for alopecia areata in children: a randomized clinical trial.
OBJECTIVE
Alopecia areata is an idiopathic cause of hair loss with limited therapeutic repertoire.


OBJECTIVE
To compare the efficacy and safety of a high- vs low-potency topical corticosteroid in pediatric patients.


METHODS
This single-center, randomized, blind, 2-arm, parallel-group, superiority trial was carried out over a 24-week period at a tertiary referral academic dermatology clinic at The Hospital for Sick Children in Toronto, Ontario, Canada. Forty-two children attending the outpatients clinic, 2 to 16 years of age with alopecia areata affecting at least 10% of scalp surface area, were eligible; 1 declined to participate. There were no withdrawals from the study. INTERVENTIONS FOR CLINICAL TRIALS: Patients were randomly assigned to receive clobetasol propionate, 0.05% cream, or hydrocortisone, 1%, cream. Patients applied a thin layer of the assigned cream twice daily to the areas of hair loss for 2 cycles of 6 weeks on, 6 weeks off, for a total of 24 weeks.


METHODS
The primary outcome was the change in scalp surface area with hair loss over 24 weeks following enrollment. RESULTS All participants were assessed at 6, 12, 18, and 24 weeks (except 1 participant who missed the 6-week visit). After adjusting for baseline hair loss, the clobetasol group had a statistically significant (P < .001) greater decrease in the surface area with hair loss, compared with the hydrocortisone group at all time points except at 6 weeks. One patient with extensive alopecia areata experienced skin atrophy that resolved spontaneously in 6 weeks. There was no difference observed in the number of patients with abnormal urinary cortisol at the beginning and the end of the study.


CONCLUSIONS
Topical clobetasol propionate, 0.05%, cream is efficacious and safe as a first-line agent for limited patchy childhood alopecia areata. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01453686.
Department of Dermatology, The Children's University Hospital, Dublin, Ireland.
Patsy
P
Lenane
Department of Dermatology, The Hospital for Sick Children, Toronto, Ontario, Canada.
Colin
C
Macarthur
Department of Dermatology, The Hospital for Sick Children, Toronto, Ontario, Canada.
Patricia C
PC
Parkin
Department of Dermatology, The Hospital for Sick Children, Toronto, Ontario, Canada.
Bernice
B
Krafchik
Department of Dermatology, The Hospital for Sick Children, Toronto, Ontario, Canada.
Julie
J
DeGroot
Department of Dermatology, The Hospital for Sick Children, Toronto, Ontario, Canada.
Amina
A
Khambalia
Department of Dermatology, The Pediatric Outcomes Research Team, The Hospital for Sick Children, Toronto, Ontario, Canada.
Elena
E
Pope
D000287:Administration, Topical; D000293:Adolescent; D000506:Alopecia Areata / Q000188:drug therapy* / Q000473:pathology; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D002990:Clobetasol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D006854:Hydrocortisone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D013997:Time Factors; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids; D002990:Clobetasol; D006854:Hydrocortisone