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RECRUITING

NCT07029204

EARLY_PHASE1

Intralesional Cyclosporine for Alopecia Areata

Sponsor: University of California, Davis

View on ClinicalTrials.gov

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.

Official title: Pilot Study on Intralesional Cyclosporine for Alopecia Areata

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-08-19

Completion Date

2026-10-01

Last Updated

2025-09-12

Healthy Volunteers

Conditions

Alopecia Areata

Interventions

DRUG

CycloSPORINE Injectable Product

Intralesional 0.5-2 mL injections of cyclosporine (2.5 mg/ml)

DRUG

Saline Solution

Intralesional 0.5-2 mL injections of Saline Solution

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 antibodies), intralesional corticosteroid injections, topical therapies, and phototherapy Exclusion Criteria: * Currently experiencing other forms of alopecia. Including but not limited to: androgenetic alopecia, telogen effluvium, or any other concomitant conditions (eg, tinea capitis, psoriasis, lupus erythematosus, or secondary syphilis) that could interfere with evaluation of alopecia areata * Previous treatment with cyclosporine * Other autoimmune diseases * Pregnancy or lactation * Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking study drug or interfere with the interpretation of data. These may include, but are not limited to, patients with untreated hypertension, patients with known renal disease with decreased GFR, and known infection. * Adults unable to consent * Prisoners * Currently using drugs that are well-substantiated to interact with cyclosporine, including the following: ciprofloxacin, gentamicin, tobramycin, trimethoprim with sulfamethaxazole, vancomycin, melphalan, amphotericin B, ketoconazole, azapropazon, colchicine, diclofenac, naproxen, sulindac, cimetidine, ranitidine, tacrolimus, fibric acid derivatives (e.g. bezafibrate, fenofibrate), and methotrexate.

Locations (1)

University of California, Davis - Dermatology Department

Sacramento, California, United States