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

Phase 3

Completed

• Conditions: Alopecia Areata
• Interventions: Drug: Hydrocortisone 1%; Drug: Clobetasol Propionate 0.05%

• Registration Number: NCT01453686
• Lead Sponsor: The Hospital for Sick Children

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 Description

Not available

Study Timeline

• Study Start: 2002-08
• Primary Completion: 2003-08
• Study Completion: 2003-08
• Study First Submitted: 2011-10-13
• Study First Submitted QC: 2011-10-17
• Study First Posted: 2011-10-18
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-06
• Last Update Posted: 2013-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrocortisone 1%	Hydrocortisone 1%	-
Clobetasol Propionate 0.05%	Clobetasol Propionate 0.05%	-

Primary Outcome Measures

Name	Time	Method
Change in scalp surface area affected over time	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.

Secondary Outcome Measures

Name	Time	Method
Change in scalp surface area affected from baseline to end of study	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	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.

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada