NCT07029204 Intralesional Cyclosporine for Alopecia Areata
| NCT ID | NCT07029204 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of California, Davis |
| Condition | Alopecia Areata |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2025-08-19 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2025-08-19 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Oma Agbai, MD
PRINCIPAL INVESTIGATOR
UC Davis Health Department of Dermatology
Frequently Asked Questions
Who can join the NCT07029204 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Alopecia Areata. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07029204 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07029204 currently recruiting?
Yes, NCT07029204 is actively recruiting participants. Contact the research team at sanasim@ucdavis.edu for enrollment information.
Where is the NCT07029204 trial being conducted?
This trial is being conducted at Sacramento, United States.
Who is sponsoring the NCT07029204 clinical trial?
NCT07029204 is sponsored by University of California, Davis. The principal investigator is Oma Agbai, MD at UC Davis Health Department of Dermatology. The trial plans to enroll 12 participants.