Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-30 @ 6:48 AM
Study NCT ID:
NCT07029204
Status:
RECRUITING
Last Update Posted:
2025-09-12
First Post:
2025-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intralesional Cyclosporine for Alopecia Areata
Sponsor:
University of California, Davis
Organization:
Study Overview
Official Title:
Pilot Study on Intralesional Cyclosporine for Alopecia Areata
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: