Intralesional Cyclosporine for Alopecia Areata

NCT ID: NCT07029204

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-19
• Study Completion Date: 2026-10-01

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.

Detailed 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 Tool score of <20 at week 36, thus demonstrating a need for more efficacious therapies.5

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, particularly with severe and recalcitrant disease course, systemic side effects of oral cyclosporine often limit its long-term use. These risks include hypertension, nephrotoxicity, prolonged immunosuppression, hyperkalemia, and hypomagnesemia.9 In consideration of these systemic adverse effects, it is important to investigate alternatives mechanisms of drug administration, including intralesional injections, to facilitate more localized drug delivery while minimizing systemic toxicity.

Oral cyclosporine has been used in the treatment of alopecia areata as a steroid-sparing agent. 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. Each participant will be evaluated and two similar areas affected by alopecia areata will be selected. These two areas will be randomly assigned to either treatment or placebo. Both participants and investigators will be blinded to treatment assignments. The participant will receive the two weekly injections, a disease activity assessment, a physical examination, vital collection, standardized photography, and surveys during each visit in the treatment phase of the study. Blood work will be completed biweekly. After week 8, one follow up will be scheduled during week 12 where the participant will be assessed again.

Through conducting this study, the study team aims to collect preliminary insights regarding the safety, dosing, and efficacy of intralesional cyclosporine for alopecia areata, guiding future larger-scale investigations.

Conditions

Alopecia Areata

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

CycloSPORINE Injectable Product

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Saline Solution

Intervention Type: DRUG

Intralesional 0.5-2 mL injections of Saline Solution

Interventions

CycloSPORINE Injectable Product

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

Intervention Type: DRUG

Saline Solution

Intralesional 0.5-2 mL injections of Saline Solution

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oma Agbai, MD

Role: PRINCIPAL_INVESTIGATOR

UC Davis Health Department of Dermatology

Locations

University of California, Davis - Dermatology Department

Sacramento, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Salsala Nasim, BS

Role: CONTACT

sanasim@ucdavis.edu

916-551-2636

Facility Contacts

Salsala Nasim, BS

Role: primary

sanasim@ucdavis.edu

916-551-2636

Other Identifiers

2168339

Identifier Type: -

Identifier Source: org_study_id