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Clobetasol propionate, 0.05%, vs hydrocortisone, 1%, for alopecia areata in children: a randomized clinical trial.
JAMA Dermatol. 2014 Jan; 150(1):47-50.JD

Abstract

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.

Authors+Show Affiliations

Department of Dermatology, The Children's University Hospital, Dublin, Ireland.Department of Dermatology, The Hospital for Sick Children, Toronto, Ontario, Canada.Department of Dermatology, The Hospital for Sick Children, Toronto, Ontario, Canada.Department of Dermatology, The Hospital for Sick Children, Toronto, Ontario, Canada.Department of Dermatology, The Hospital for Sick Children, Toronto, Ontario, Canada.Department of Dermatology, The Hospital for Sick Children, Toronto, Ontario, Canada.Department of Dermatology, The Pediatric Outcomes Research Team, The Hospital for Sick Children, Toronto, Ontario, Canada.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24226568

Citation

Lenane, Patsy, et al. "Clobetasol Propionate, 0.05%, Vs Hydrocortisone, 1%, for Alopecia Areata in Children: a Randomized Clinical Trial." JAMA Dermatology, vol. 150, no. 1, 2014, pp. 47-50.
Lenane P, Macarthur C, Parkin PC, et al. Clobetasol propionate, 0.05%, vs hydrocortisone, 1%, for alopecia areata in children: a randomized clinical trial. JAMA Dermatol. 2014;150(1):47-50.
Lenane, P., Macarthur, C., Parkin, P. C., Krafchik, B., DeGroot, J., Khambalia, A., & Pope, E. (2014). Clobetasol propionate, 0.05%, vs hydrocortisone, 1%, for alopecia areata in children: a randomized clinical trial. JAMA Dermatology, 150(1), 47-50. https://doi.org/10.1001/jamadermatol.2013.5764
Lenane P, et al. Clobetasol Propionate, 0.05%, Vs Hydrocortisone, 1%, for Alopecia Areata in Children: a Randomized Clinical Trial. JAMA Dermatol. 2014;150(1):47-50. PubMed PMID: 24226568.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clobetasol propionate, 0.05%, vs hydrocortisone, 1%, for alopecia areata in children: a randomized clinical trial. AU - Lenane,Patsy, AU - Macarthur,Colin, AU - Parkin,Patricia C, AU - Krafchik,Bernice, AU - DeGroot,Julie, AU - Khambalia,Amina, AU - Pope,Elena, PY - 2013/11/15/entrez PY - 2013/11/15/pubmed PY - 2014/3/14/medline SP - 47 EP - 50 JF - JAMA dermatology JO - JAMA Dermatol VL - 150 IS - 1 N2 - 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. SN - 2168-6084 UR - https://www.unboundmedicine.com/medline/citation/24226568/Clobetasol_propionate_0_05_vs_hydrocortisone_1_for_alopecia_areata_in_children:_a_randomized_clinical_trial_ L2 - https://jamanetwork.com/journals/jamadermatology/fullarticle/10.1001/jamadermatol.2013.5764 DB - PRIME DP - Unbound Medicine ER -