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

Primary Purpose

Alopecia Areata

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Hydrocortisone 1%
Clobetasol Propionate 0.05%
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata focused on measuring Alopecia Areata, Hydrocortisone, Clobetasol Propionate, Randomized Controlled Trial

Eligibility Criteria

2 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Hydrocortisone 1%

Clobetasol Propionate 0.05%

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 13, 2011
Last Updated
December 6, 2013
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT01453686
Brief Title
A Trial of Clobetasol Propionate Versus Hydrocortisone in Children With Alopecia Areata
Official Title
A Randomized Controlled Trial of Clobetasol Propionate 0.05% Cream Versus Hydrocortisone 1% Cream in Children With Alopecia Areata
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
August 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
Keywords
Alopecia Areata, Hydrocortisone, Clobetasol Propionate, Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydrocortisone 1%
Arm Type
Experimental
Arm Title
Clobetasol Propionate 0.05%
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone 1%
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Clobetasol Propionate 0.05%
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in scalp surface area affected over time
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change in scalp surface area affected from baseline to end of study
Description
The percent change in scalp surface area affected on the scalp will be compared between the intervention groups from baseline to 24 weeks.
Time Frame
24 weeks
Title
Over 50% reduction in scalp surface area affected
Description
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.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colin Macarthur, MBChB, PhD
Organizational Affiliation
The Hospital for Sick Children, Toronto, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
24226568
Citation
Lenane P, Macarthur C, Parkin PC, Krafchik B, DeGroot J, Khambalia A, Pope E. Clobetasol propionate, 0.05%, vs hydrocortisone, 1%, for alopecia areata in children: a randomized clinical trial. JAMA Dermatol. 2014 Jan;150(1):47-50. doi: 10.1001/jamadermatol.2013.5764.
Results Reference
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A Trial of Clobetasol Propionate Versus Hydrocortisone in Children With Alopecia Areata

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