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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Patricia Parkin, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01453686
First received: October 13, 2011
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Alopecia Areata
Drug: Hydrocortisone 1%
Drug: Clobetasol Propionate 0.05%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Clobetasol Propionate 0.05% Cream Versus Hydrocortisone 1% Cream in Children With Alopecia Areata

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Change in scalp surface area affected over time [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 41
Study Start Date: August 2002
Study Completion Date: August 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hydrocortisone 1% Drug: 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.
Experimental: Clobetasol Propionate 0.05% 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.

  Eligibility

Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01453686

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Colin Macarthur, MBChB, PhD The Hospital for Sick Children, Toronto, Canada
  More Information

No publications provided by The Hospital for Sick Children

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Patricia Parkin, Staff Paediatrician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01453686     History of Changes
Other Study ID Numbers: 0020020248
Study First Received: October 13, 2011
Last Updated: December 6, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
Alopecia Areata
Hydrocortisone
Clobetasol Propionate
Randomized Controlled Trial

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Clobetasol
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dermatologic Agents

ClinicalTrials.gov processed this record on April 15, 2014