Intralesional Cyclosporine for Alopecia Areata

NCT07029204 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 2168339
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia Areata

Keywords

Alopecia Areata; Cyclosporine; Intralesional Injection

Outcome Measures

Primary Outcomes (3)

• Hair Regrowth: SALT Score

  Using the Severity of Alopecia Tool (SALT), study team will track and monitor the percentage of scalp hair loss throughout participant's duration in the trial.

  Screening to Week 12

• Hair Regrowth: PRO for scalp hair assessment

  PRO for scalp hair assessment will be a questionnaire given to participants where they will elevate their hair loss on a scale of 0-4.

  Week 0 and Week 12

• Hair Regrowth: Standardized photographs

  Standardized photographs of participant's scalps will be taken throughout the course of the study to visual monitor outcomes. There will be a minimum of 5 photographs taken: one of each of the 4 planes of scalp and 1 frontal view of face and scalp. These photographs will be compared to one another through the study to assess the hair regrowth that occurred following the cyclosporine injections.

  Week 0 to Week 12

Secondary Outcomes (8)

• Safety End Point: Adverse Events

  Screening to Week 12

• Liver Function: Alanine transaminase (ALT), Aspartate transaminase (AST), Alkaline phosphatase (ALP) measured in units per liter (U/L)

  Week 0 to Week 12

• Kidney Function: Blood Urea Nitrogen (BUN) and Creatinine measured in milligrams per deciliter (mg/dL)

  Week 0 to Week 12

• Number of participants with abnormal Complete Blood Count (CBC)

  Week 0 to Week 12

• Cyclosporine levels measured in nanograms per milliliter (ng/mL)

  Week 0 to Week 12

Study Arms (2)

Blinded Cyclosporine Injection

EXPERIMENTAL

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.

Drug: CycloSPORINE Injectable Product

Blinded Placebo Injection

PLACEBO COMPARATOR

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.

Drug: Saline Solution

Interventions

CycloSPORINE Injectable Product DRUG

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

Blinded Cyclosporine Injection

Saline Solution DRUG

Intralesional 0.5-2 mL injections of Saline Solution

Blinded Placebo Injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis - Dermatology Department

Sacramento, California, 95816, United States

RECRUITING

MeSH Terms

Conditions

Alopecia Areata

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Oma Agbai, MD

  UC Davis Health Department of Dermatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Salsala Nasim, BS

CONTACT

916-551-2636; sanasim@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: June 19, 2025
• Study Start: August 19, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

US (1)