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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: The Hospital for Sick Children

Current Primary Outcome: Change in scalp surface area affected over time [ Time Frame: 24 weeks ]

The change in scalp surface area affected will be compared between the two intervention groups from baseline to 6 weeks, 12 weeks, and 24 weeks.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in scalp surface area affected from baseline to end of study [ Time Frame: 24 weeks ]
    The percent change in scalp surface area affected on the scalp will be compared between the intervention groups from baseline to 24 weeks.
  • Over 50% reduction in scalp surface area affected [ Time Frame: 24 weeks ]
    The number of subjects who had over 50% reduction in scalp surface area affected from baseline to 24 weeks will be compared between the intervention groups.


Original Secondary Outcome: Same as current

Information By: The Hospital for Sick Children

Dates:
Date Received: October 13, 2011
Date Started: August 2002
Date Completion:
Last Updated: December 6, 2013
Last Verified: December 2013