Pilot Study on Intralesional Cyclosporine for Alopecia Areata

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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 antibodies), intralesional corticosteroid injections, topical therapies, and phototherapy

Locations
United States
California
University of California, Davis - Dermatology Department
RECRUITING
Sacramento
Contact Information
Primary
Salsala Nasim, BS
sanasim@ucdavis.edu
916-551-2636
Time Frame
Start Date: 2025-08-19
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 12
Treatments
Experimental: Blinded Cyclosporine Injection
Two lesions on each participant are chosen and randomized. One lesion will receive an intralesional injection of 0.5-2 mL of cyclosporine (2.5 mg/ml) depending on lesion size. The injection will be given weekly for 8 weeks.
Placebo_comparator: Blinded Placebo Injection
Two lesions on each participant are chosen and randomized. One lesion will receive an intralesional injection of 0.5-2 mL of saline solution depending on lesion size. The injection will be given weekly for 8 weeks.
Sponsors
Leads: University of California, Davis

This content was sourced from clinicaltrials.gov

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