Pilot Study on Intralesional Cyclosporine for Alopecia Areata
University of California, Davis
Summary
Alopecia areata (AA) is a chronic autoimmune disease that causes non-scarring, focal areas of hair loss. Due to its resulting disfigurement and unpredictable course, it is recognized as a serious medical condition with severe emotional and psychosocial distress, including a high prevalence of depression and anxiety.1-4 Treatment options for alopecia areata are limited. Cyclosporine has been used as an effective therapeutic option in the treatment of psoriasis. Additionally, the use of oral cyclosporine, alone or in combination with other agents, has been used in the management of a multitude of dermatologic conditions, including alopecia areata, pyoderma gangrenosum, chronic idiopathic purpura, atopic dermatitis, dyshidrotic eczema, Behcet disease, dermatomyositis, among others.8 Although cyclosporine has demonstrated efficacy in the management of these diseases, systemic side effects of oral cyclosporine often limit its long-term use. However, intralesional injections of cyclosporine have not been investigated. Through this randomized double-blind placebo-controlled clinical study, the study team aims to evaluate the safety, dosing, and efficacy of intralesional cyclosporine for use in the treatment of alopecia areata. The study team expects about 12 people at UC Davis to take part in this research. The study itself includes 11 visits and will last about 12 weeks.
Description
Alopecia areata (AA) is a chronic autoimmune disease that causes non-scarring, focal areas of hair loss. Due to its resulting disfigurement and unpredictable course, it is recognized as a serious medical condition with severe emotional and psychosocial distress, including a high prevalence of depression and anxiety.1-4 Treatment options for alopecia areata are limited. Currently, baricitinib is the only FDA-approved treatment for alopecia areata. However, in clinical trials, only 39% of patients receiving the highest dose of baricitinib achieved the primary endpoint of a Severity of Alopecia T…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age between 18 and 65 at screening visit. * Diagnosis of alopecia areata by a board-certified dermatologist at screening visit. * Current alopecia areata episode involving the scalp of more than 3 months' duration prior to baseline visit. * SALT Score between 10 and 50 at baseline visit. * Stable disease based on subject history over the past 1 month. * Agree not to use any alopecia areata treatments during the study, including, but not limited to: systemic therapies (eg, methotrexate, cyclosporine, corticosteroids, JAK inhibitors) and biologics (eg, monoclonal antibodie…
Interventions
- DrugCycloSPORINE Injectable Product
Intralesional 0.5-2 mL injections of cyclosporine (2.5 mg/ml)
- DrugSaline Solution
Intralesional 0.5-2 mL injections of Saline Solution
Location
- University of California, Davis - Dermatology DepartmentSacramento, California