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Completed

NCT Number: NCT01453686

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

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.

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Key information

Conditions

Alopecia Areata Alopecia Hair Diseases Hypotrichosis Skin Diseases Skin and Connective Tissue Diseases

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrocortisone 1%

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%

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.

Primary outcomes

  1. Change in scalp surface area affected over time

    Time frame: 24 weeks

    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 outcomes

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

    Time frame: 24 weeks

    The percent change in scalp surface area affected on the scalp will be compared between the intervention groups from baseline to 24 weeks.

  2. Over 50% reduction in scalp surface area affected

    Time frame: 24 weeks

    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.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Oct 18, 2011
Registry last updated
Dec 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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