At a glance
ClinicalIndex Comparison Record- ✓Age 18–65 years at informed consent
- ✓Diagnosed scalp alopecia areata (not diffuse)
- ✓50–95% patchy scalp hair loss from alopecia areata lasting ≥1 year
- ✓CD4+ T-lymphocyte counts at or above lower limit of normal
- ✕History of malignancy (except ≤3 treated squamous cell carcinomas or treated basal cell carcinoma)
- ✕Evidence of immunocompromise
- ✕Advanced or poorly controlled diabetes
- ✕Unstable cardiovascular disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind, Placebo-Controlled, Randomized, Multi-Center Study to Evaluate The Safety and Therapeutic Efficacy of Intramuscular Administration of Alefacept in Patients With Chronic, Severe Scalp Alopecia Areata
In Brief
A clinical study evaluating Alefacept for Alopecia Areata. Completed, enrolled 45 participants across 1 site.
Detailed Summary
The purpose of this study is to examine prospectively the safety and efficacy of alefacept in the treatment of subjects with severe alopecia areata of the scalp. Common features between psoriasis and alopecia areata, including immunologic and therapeutic aspects, suggest that alefacept, which has been shown to be a safe and statistically significant beneficial therapeutic modality for the treatment of psoriasis, may have therapeutic value in alopecia areata.
Study Details
Timeline
Interventions
Study participants will receive weekly IM administration of placebo or 15 mg of alefacept for 12 weeks, to be followed by a 12-week post-treatment period during which the safety, efficacy, and durability of effect in treatment responders will be assessed on weeks 2, 4, 8 and 12.