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

NCT ID: NCT01453686

Last Updated: 2013-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2003-08-31

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.

Detailed Description

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Conditions

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Alopecia Areata

Keywords

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Alopecia Areata Hydrocortisone Clobetasol Propionate Randomized Controlled Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Hydrocortisone 1%

Group Type EXPERIMENTAL

Hydrocortisone 1%

Intervention Type DRUG

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%

Group Type EXPERIMENTAL

Clobetasol Propionate 0.05%

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

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
Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Patricia Parkin

Staff Paediatrician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Colin Macarthur, MBChB, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto, Canada

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 24226568 (View on PubMed)

Other Identifiers

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0020020248

Identifier Type: -

Identifier Source: org_study_id