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

Alopecia Areata Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01453686
• Other study ID #: 0020020248
• Status: Completed
• Phase: Phase 3
• First received: October 13, 2011
• Last updated: December 6, 2013
• Start date: August 2002
• Est. completion date: August 2003

Study information

• Verified date: December 2013
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 2003
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 16 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• Hydrocortisone 1%
Topical cream, used twice daily for 6 weeks on affected area, followed by 6 weeks of no treatment, followed by an additional 6 weeks of the same intervention.
• Clobetasol Propionate 0.05%
Topical cream, used twice daily for 6 weeks on affected area, followed by 6 weeks of no treatment, followed by an additional 6 weeks of the same intervention.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in scalp surface area affected over time	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.	24 weeks	No
Secondary	Change in scalp surface area affected from baseline to end of study	The percent change in scalp surface area affected on the scalp will be compared between the intervention groups from baseline to 24 weeks.	24 weeks	No
Secondary	Over 50% reduction in scalp surface area affected	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.	24 weeks	No