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

The Hospital for Sick Children

Status and phase: Completed; Phase 3

Conditions: Alopecia Areata

Treatments: Drug: Hydrocortisone 1%; Drug: Clobetasol Propionate 0.05%

Study type: Interventional

Funder types: Other

Identifiers

NCT01453686

0020020248

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

41 participants in 2 patient groups

Hydrocortisone 1%

Experimental group

Treatment:

Drug: Hydrocortisone 1%

Clobetasol Propionate 0.05%

Experimental group

Treatment:

Drug: Clobetasol Propionate 0.05%