Alopecia AreataEarly Phase 1NCT07029204
Intralesional Cyclosporine for Alopecia Areata
A Early Phase 1 study testing CycloSPORINE Injectable Product and Saline Solution in people with Alopecia Areata, run by University of California, Davis at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- CycloSPORINE Injectable Product and Saline Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2025to 1 Oct 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis - Dermatology Department
Sacramento, California, 95816
About this study
Official title: Pilot Study on Intralesional Cyclosporine for Alopecia Areata
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.
Read the 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
- Being tested
- CycloSPORINE Injectable Product, Saline Solution
- Keywords
- Alopecia Areata, Cyclosporine, Intralesional Injection
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CycloSPORINE Injectable ProductDrug
Intralesional 0.5-2 mL injections of cyclosporine (2.5 mg/ml)
Saline SolutionDrug
Intralesional 0.5-2 mL injections of Saline Solution
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Week 0 to Week 12
Secondary outcomes (8)
Safety End Point: Adverse Events
To assess any adverse events that may be associated with the study or its procedures
Measured: Screening to Week 12
Liver Function: Alanine transaminase (ALT), Aspartate transaminase (AST), Alkaline phosphatase (ALP) measured in units per liter (U/L)
Blood samples will be used to evaluate ALT, AST, and ALP levels to determine if cyclosporine or study procedures may affect liver function.
Measured: Week 0 to Week 12
Kidney Function: Blood Urea Nitrogen (BUN) and Creatinine measured in milligrams per deciliter (mg/dL)
Blood samples will be used to evaluate BUN and Creatinine levels to determine if cyclosporine or study procedures may affect kidney function.
Measured: Week 0 to Week 12
Number of participants with abnormal Complete Blood Count (CBC)
Through patient blood samples, abnormalities in CBC will be noted and the total number of patients will be evaluated.
Measured: Week 0 to Week 12
Cyclosporine levels measured in nanograms per milliliter (ng/mL)
Blood samples will be used to evaluate cyclosporine levels in blood due to intralesional cyclosporine injection.
Measured: Week 0 to Week 12
Blood Pressure measured in millimeters of mercury (mm Hg)
Diastolic and Systolic blood pressure will be collected before and after intralesional injection throughout the study to assess if cyclosporine or study procedures may have an effect.
Measured: Screening to Week 12
Heart Rate measured in beats per minute (b/m)
Heart rate will be measured using a vital machine before and after intralesional injection throughout the study to assess if cyclosporine or study procedures may have an effect.
Measured: Screening to Week 12
Temperature measured in Fahrenheit (F)
Temperature will be measured using a thermometer before and after intralesional injection throughout the study to assess if cyclosporine or study procedures may have an effect.
Measured: Screening to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start19 Aug 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oma Agbai, MD, Principal investigator, UC Davis Health Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029204
- Sponsor's protocol ID
- 2168339
- Status last verified
- Aug 2026
- First submitted
- 8 May 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Intralesional Cyclosporine for Alopecia Areata
- ClinicalTrials.gov ID
- NCT07029204
- Acronym / sponsor ID
- 2168339
- Conditions
- Alopecia Areata
- Keywords
- Alopecia Areata, Cyclosporine, Intralesional Injection
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blinded Cyclosporine Injection | Experimental | Drug: CycloSPORINE Injectable ProductTwo 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. |
| Blinded Placebo Injection | Placebo comparator | Drug: Saline SolutionTwo 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CycloSPORINE Injectable ProductIntralesional 0.5-2 mL injections of cyclosporine (2.5 mg/ml) | Drug | Blinded Cyclosporine Injection |
| Saline SolutionIntralesional 0.5-2 mL injections of Saline Solution | Drug | Blinded Placebo Injection |
Primary outcome
Hair Regrowth: SALT Score
Time frame: Screening to Week 12
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.
Hair Regrowth: PRO for scalp hair assessment
Time frame: Week 0 and Week 12
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.
Hair Regrowth: Standardized photographs
Time frame: Week 0 to Week 12
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.
8 secondary outcomes
Safety End Point: Adverse Events
Time frame: Screening to Week 12
Liver Function: Alanine transaminase (ALT), Aspartate transaminase (AST), Alkaline phosphatase (ALP) measured in units per liter (U/L)
Time frame: Week 0 to Week 12
Kidney Function: Blood Urea Nitrogen (BUN) and Creatinine measured in milligrams per deciliter (mg/dL)
Time frame: Week 0 to Week 12
Number of participants with abnormal Complete Blood Count (CBC)
Time frame: Week 0 to Week 12
Cyclosporine levels measured in nanograms per milliliter (ng/mL)
Time frame: Week 0 to Week 12
Blood Pressure measured in millimeters of mercury (mm Hg)
Time frame: Screening to Week 12
Heart Rate measured in beats per minute (b/m)
Time frame: Screening to Week 12
Temperature measured in Fahrenheit (F)
Time frame: Screening to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
Related trials for Alopecia Areata
Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
Active, not recruitingObservational study
Litfulo Capsules Special Investigation
Alopecia Areata
Active, not recruitingObservational study
Real-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data
Alopecia Areata
Active, not recruitingObservational study
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Alopecia Areata
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oma Agbai, MD principal investigator
UC Davis Health Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CycloSPORINE Injectable Product and Saline Solution in people with Alopecia Areata, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair Regrowth: SALT Score (time frame: Screening to Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.