Cyclosporine Injections for Alopecia Areata
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether cyclosporine injections can safely and effectively treat alopecia areata, a condition causing patchy hair loss. While cyclosporine is used for other skin conditions, its injections for alopecia areata remain unstudied. Participants will receive either cyclosporine or a placebo injection to compare results. Individuals with alopecia areata affecting their scalp for more than three months, who are not currently using other treatments, may be eligible. As an Early Phase 1 trial, this research aims to understand how cyclosporine injections work in people, offering participants a chance to explore this potential treatment for alopecia areata.
Do I need to stop my current medications to join the trial?
Yes, you will need to stop using any treatments for alopecia areata during the study, including systemic therapies, biologics, and topical treatments. Additionally, you cannot use drugs that interact with cyclosporine, such as certain antibiotics and anti-inflammatory medications.
What prior data suggests that intralesional cyclosporine injections are safe for treating alopecia areata?
Research has used cyclosporine to treat various skin conditions, such as alopecia areata, which causes hair loss in patches. Oral cyclosporine has shown some success, but side effects limit its long-term use because the medicine affects the entire body. However, injecting cyclosporine directly into the affected area remains largely unstudied.
This trial is in its early stages, providing limited information about the safety of cyclosporine injections in people. Early trials typically aim to determine safe dosage levels and monitor for side effects. Since cyclosporine is already used for other conditions, it suggests some level of safety, but injections may work differently than oral administration.
Prospective participants should know that while cyclosporine has been studied in other forms, its use as an injection is still new and undergoing safety testing.12345Why do researchers think this study treatment might be promising for alopecia areata?
Cyclosporine injections are unique because they offer a new delivery method for treating alopecia areata, a condition where the immune system mistakenly attacks hair follicles. Most current treatments, like topical corticosteroids or oral immunosuppressants, can have widespread effects on the body. However, cyclosporine injections target specific lesions directly, potentially reducing systemic side effects. Researchers are excited because this localized approach could provide a more effective and safer treatment option for patients struggling with hair loss due to alopecia areata.
What evidence suggests that cyclosporine injections might be an effective treatment for alopecia areata?
Research has shown that cyclosporine may help treat various skin conditions. It has proven effective for psoriasis and somewhat effective for alopecia areata (AA) when taken as a pill. In one study, about 65% of patients taking oral cyclosporine experienced some hair regrowth. However, long-term oral use can cause side effects. This trial will test cyclosporine injections directly into the skin to evaluate their effectiveness with fewer side effects. Participants will receive either a cyclosporine injection or a placebo injection. Although limited information exists on using injected cyclosporine for AA, researchers hope it will be effective.12346
Who Is on the Research Team?
Oma Agbai, MD
Principal Investigator
UC Davis Health Department of Dermatology
Are You a Good Fit for This Trial?
This trial is for individuals with alopecia areata, a condition causing patchy hair loss. Participants should be willing to undergo multiple visits over 12 weeks at UC Davis and have not been treated with cyclosporine before. Specific inclusion and exclusion criteria details were not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive weekly intralesional injections of cyclosporine or placebo for 8 weeks, with disease activity assessments, physical examinations, vital collection, standardized photography, surveys, and biweekly blood work
Follow-up
Participants are monitored for safety and effectiveness after treatment, with a final assessment at week 12
What Are the Treatments Tested in This Trial?
Interventions
- Cyclosporine
Trial Overview
The study tests intralesional injections of CycloSPORINE against saline solution in a double-blind setup, meaning neither the participants nor the researchers know who receives which treatment until after the results are collected.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Davis
Lead Sponsor
Citations
Intralesional Cyclosporine for Alopecia Areata
The study team aims to evaluate the safety, dosing, and efficacy of intralesional cyclosporine for use in the treatment of alopecia areata.
Cyclosporine With and Without Systemic Corticosteroids in ...
The mean response rate in the whole group of patients at the end of treatment was 65.00% (221/340; range 25–100%). Hair regrowth rate was higher ...
Alopecia Areata Treatment & Management
Another study of 14 patients using a 5% solution of cyclosporine twice per day for 4-6 months reported vellus growth in 3 of 14 patients and ...
4.
journals.lww.com
journals.lww.com/ders/fulltext/9900/real_world_evidence_in_alopecia_areata_treatment_.143.aspxReal-world evidence in alopecia areata treatment
Oral cyclosporine (CsA) is moderately effective for AA, particularly in steroid responsive but dependent cases. A double-blind randomized ...
Treatment of Severe Alopecia Areata: Combination ...
Conclusion: We found that combination therapy with systemic CsA and low-dose corti- costeroids effectively treats severe AA and this therapy results in a safe, ...
A Comparative Study of Oral Cyclosporine and ...
In the cyclosporine group, patients with mild AA were found to respond better to the treatment. Based on the patient self-assessments, 70.6% of ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.