Clobetasol propionate, 0.05%, vs hydrocortisone, 1%, for alopecia areata in
children: a randomized clinical trial.
Author(s): Lenane P(1), Macarthur C(2), Parkin PC(2), Krafchik B(2), DeGroot J(2), Khambalia
A(2), Pope E(3).
Affiliation(s): Author information:
(1)Department of Dermatology, The Children's University Hospital, Dublin, Ireland.
(2)Department of Dermatology, The Hospital for Sick Children, Toronto, Ontario,
Canada.
(3)Department of Dermatology, The Pediatric Outcomes Research Team, The Hospital for
Sick Children, Toronto, Ontario, Canada.
Publication date & source: 2014, JAMA Dermatol. , 150(1):47-50
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.
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