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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
12
Intralesional 0.5-2 mL injections of cyclosporine (2.5 mg/ml)
Intralesional 0.5-2 mL injections of Saline Solution
University of California, Davis - Dermatology Department
Sacramento, California, United States
RECRUITINGHair 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 0 to Week 12
Safety End Point: Adverse Events
To assess any adverse events that may be associated with the study or its procedures
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Screening to Week 12
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