Intralesional Cyclosporine for Alopecia Areata

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT07029204
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • CycloSPORINE Injectable Product — DRUG
    Intralesional 0.5-2 mL injections of cyclosporine (2.5 mg/ml)
  • Saline Solution — DRUG
    Intralesional 0.5-2 mL injections of Saline Solution

Study Details

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.

Key Dates

Start date
Aug 19, 2025
Status verified
Sep 2025
Primary completion
Jul 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Placebo Comparator: 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.

Primary Outcome Measure

Hair Regrowth: SALT Score [ Time Frame: Screening to Week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, Davis - Dermatology DepartmentSacramentoCalifornia95816
Salsala Nasim, BS
[email protected]
916-551-2636

Find similar trials in Sacramento, CA

By research site
University of California, Davis - Dermatology Department· Sacramento, CA

Related Studies