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

NCT01453686 | Completed Phase 3

• 1 other identifier: 0020020248
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia Areata

Keywords

Alopecia Areata; Hydrocortisone; Clobetasol Propionate; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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.

  24 weeks

Secondary Outcomes (2)

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

  24 weeks

• Over 50% reduction in scalp surface area affected

  24 weeks

Study Arms (2)

Hydrocortisone 1%

EXPERIMENTAL

Drug: Hydrocortisone 1%

Clobetasol Propionate 0.05%

EXPERIMENTAL

Drug: Clobetasol Propionate 0.05%

Interventions

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.

Hydrocortisone 1%

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.

Clobetasol Propionate 0.05%

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 2 to 16 years
• New patients presenting to The Hospital for Sick Children
• Clinical confirmation of alopecia areata
• Hair loss between 10 -75%

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• 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.

  PMID: 24226568 DERIVED

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

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

Study Officials

• Colin Macarthur, MBChB, PhD

  The Hospital for Sick Children, Toronto, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Paediatrician

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: October 18, 2011
• Study Start: August 1, 2002
• Primary Completion: August 1, 2003
• Study Completion: August 1, 2003
• Last Updated: December 9, 2013

Record last verified: 2013-12

Locations

CA (1)