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A Trial of Clobetasol Propionate Versus Hydrocortisone in Children With Alopecia Areata

Information source: The Hospital for Sick Children
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alopecia Areata

Intervention: Hydrocortisone 1% (Drug); Clobetasol Propionate 0.05% (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: The Hospital for Sick Children

Official(s) and/or principal investigator(s):
Colin Macarthur, MBChB, PhD, Principal Investigator, Affiliation: The Hospital for Sick Children, Toronto, Canada


The use of topical steroids in the treatment of alopecia areata in children is common practice. However, no particular potency of steroid is accepted as the standard treatment due to the paucity of high quality evidence in the dermatology literature to substantiate their use. Two randomized controlled trials exist assessing topical steroid efficacy in this disorder, both have methodological limitations. The question remains as to which topical steroid is safe and efficacious for use. We performed a double blinded controlled trial to assess the usefulness of a class 1 topical steroid (clobestasol proprionate 0. 05%) compared with a class 7 topical steroid (hydrocortisone 1%) in children with alopecia areata.

Clinical Details

Official title: A Randomized Controlled Trial of Clobetasol Propionate 0.05% Cream Versus Hydrocortisone 1% Cream in Children With Alopecia Areata

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Change in scalp surface area affected over time

Secondary outcome:

Change in scalp surface area affected from baseline to end of study

Over 50% reduction in scalp surface area affected


Minimum age: 2 Years. Maximum age: 16 Years. Gender(s): Both.


Inclusion Criteria:

- Age 2 to 16 years

- New patients presenting to The Hospital for Sick Children

- Clinical confirmation of alopecia areata

- Hair loss between 10 -75%

Exclusion Criteria:

- Skin or medical problems requiring use of oral steroids

- Immunosuppressants or PUVA for 4 weeks prior to the study

- Use of inhaled and or intranasal steroids for 14 days prior to trial

- Topical medicaments for 7 days prior to the trial

Locations and Contacts

The Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada
Additional Information

Starting date: August 2002
Last updated: December 6, 2013

Page last updated: August 23, 2015

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