Intralesional cyclosporine injections for scalp alopecia areata
Pilot Study on Intralesional Cyclosporine for Alopecia Areata
This trial will try injecting cyclosporine directly into patches of scalp hair loss to see if it helps adults aged 18–65 with alopecia areata regrow hair.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Drugs / interventions | methotrexate, baricitinib |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT07029204 on ClinicalTrials.gov |
What this trial studies
This early phase 1 interventional trial delivers intralesional cyclosporine injections into affected scalp areas, with saline used as a comparator, to examine local safety and preliminary signs of hair regrowth. Eligible participants are adults with a SALT score of 10–50, an ongoing scalp episode for more than three months, and must agree to stop other alopecia treatments during the study. The protocol aims to concentrate drug at lesion sites to limit the systemic toxicity seen with oral cyclosporine. Safety monitoring will include clinical exams and laboratory checks to watch for local and systemic adverse effects.
Who should consider this trial
Good fit: Ideal candidates are adults 18–65 with scalp-limited alopecia areata for >3 months, a baseline SALT score between 10 and 50, and willingness to avoid other alopecia treatments during the study.
Not a fit: Patients with very extensive disease (SALT >50), other types of hair loss, active scalp diseases that confound assessment, recent systemic immunosuppressive therapy, or inability to attend the UC Davis site are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, intralesional cyclosporine could promote scalp hair regrowth while reducing the systemic side effects associated with oral cyclosporine.
How similar studies have performed: Oral cyclosporine has demonstrated efficacy in dermatologic conditions including alopecia areata, but intralesional cyclosporine has limited controlled data and is relatively untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sacramento, California
- University of California, Davis - Dermatology Department — Sacramento, California, United States (Recruiting)
Study contacts
- Principal investigator: Oma Agbai, MD — UC Davis Health Department of Dermatology
- Study coordinator: Salsala Nasim, BS
- Email: sanasim@ucdavis.edu
- Phone: 916-551-2636
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.