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

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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

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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Change in scalp surface area affected over time

Secondary Outcome

 Change in scalp surface area affected from baseline to end of study

Condition

Alopecia Areata

Intervention

Hydrocortisone 1%

Study Arms / Comparison Groups

 Hydrocortisone 1%
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

41

Start Date

August 2002

Completion Date

August 2003

Primary Completion Date

August 2003

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
      

Gender

All

Ages

2 Years - 16 Years

Accepts Healthy Volunteers

No

Contacts

Colin Macarthur, MBChB, PhD, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT01453686

Organization ID

0020020248


Responsible Party

Principal Investigator

Study Sponsor

The Hospital for Sick Children


Study Sponsor

Colin Macarthur, MBChB, PhD, Principal Investigator, The Hospital for Sick Children, Toronto, Canada


Verification Date

December 2013