Actively Recruiting

Early Phase 1
Age: 18Years - 65Years
All Genders
NCT07029204

Intralesional Cyclosporine for Alopecia Areata

Led by University of California, Davis · Updated on 2025-09-12

12

Participants Needed

1

Research Sites

58 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Intralesional Cyclosporine for Alopecia Areata

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 lasting more than 3 months prior to baseline visit
  • SALT Score between 10 and 50 at baseline visit
  • Stable disease based on patient history over the past 1 month
  • Agreement not to use any alopecia areata treatments during the study, including systemic therapies, biologics, intralesional corticosteroid injections, topical therapies, and phototherapy
Not Eligible

You will not qualify if you...

  • Currently experiencing other forms of alopecia such as androgenetic alopecia, telogen effluvium, or any conditions like tinea capitis, psoriasis, lupus erythematosus, or secondary syphilis that could interfere with alopecia areata evaluation
  • Previous treatment with cyclosporine
  • Presence of other autoimmune diseases
  • Pregnancy or lactation
  • History or presence of serious or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders that could pose risks or interfere with study data
  • Adults unable to consent
  • Prisoners
  • Current use of drugs known to interact with cyclosporine, including ciprofloxacin, gentamicin, tobramycin, trimethoprim with sulfamethaxazole, vancomycin, melphalan, amphotericin B, ketoconazole, azapropazon, colchicine, diclofenac, naproxen, sulindac, cimetidine, ranitidine, tacrolimus, fibric acid derivatives, and methotrexate

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California, Davis - Dermatology Department

Sacramento, California, United States, 95816

Actively Recruiting

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Research Team

S

Salsala Nasim, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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