Clobetasol Propionate, 0.05%, vs Hydrocortisone, 1%, for Alopecia Areata in Children: A Randomized Clinical Trial

P Lenane, C Macarthur, PC Parkin, B Krafchik, J Degroot, A Khambalia, E Pope

Alopecia areataABSTRACT

IMPORTANCE
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.

DESIGN, SETTING, AND PARTICIPANTS
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.

MAIN OUTCOMES AND MEASURES
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 AND RELEVANCE
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.

Alopecia areata is a nonscarring autoimmune idiopathic cause of hair loss with a prevalence of 0.1% and a lifetime risk of 1.7%.1 Pediatric cases account for 20%,2,3 and the condition can be associated with psychological distress in affected children and their families. There is a limited therapeutic repertoire for alopecia areata. Topical steroids are the most common therapy used. However, a recent Cochrane Systematic Review4 concluded that there is scant evidence for the long-term therapeutic benefit of steroids in alopecia areata, and that there is a “desperate need” for well-constructed therapeutic trials. To our knowledge, no prospective studies in children have examined any of the existing topical modalities for alopecia areata. The primary objective of our study was to determine the efficacy and safety of a class 1 topical steroid (clobetasol propionate, 0.05%) compared with a class 7 topical steroid(hydrocortisone, 1%) in the treatment of pediatric alopecia areata.

P Lenane, C Macarthur, PC Parkin, B Krafchik, J Degroot, A Khambalia, E Pope.
Clobetasol Propionate, 0.05%, vs Hydrocortisone, 1%, for Alopecia Areata in Children: A Randomized Clinical Trial
JAMA Dermatol 2013 Nov 13;[EPub Ahead of Print],