Alopecia Areata
Conditions
Keywords
Alopecia Areata, Hydrocortisone, Clobetasol Propionate, Randomized Controlled Trial
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.
Interventions
DRUGHydrocortisone 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.
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.
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in scalp surface area affected over time | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in scalp surface area affected from baseline to end of study | 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. |
| Over 50% reduction in scalp surface area affected | 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. |
Countries
Canada
Outcome results
None listed