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

Study Overview
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Brief Summary
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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.

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

Conditions
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Alopecia Areata

Intervention / Treatment
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* Drug: Hydrocortisone 1%
* Drug: Clobetasol Propionate 0.05%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrocortisone 1%<br> | Drug: Hydrocortisone 1%<br>* 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.<br>|
| Experimental: Clobetasol Propionate 0.05%<br> | Drug: Clobetasol Propionate 0.05%<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alopecia Areata, Hydrocortisone, Clobetasol Propionate, Randomized Controlled Trial