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
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.
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 studyOver 50% reduction in scalp surface area affected
Eligibility
Minimum age: 2 Years.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
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
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