Pilot Study on Intralesional Cyclosporine for Alopecia Areata
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Hair Regrowth: SALT Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: CycloSPORINE Injectable Product (Drug)
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.
干预措施: Saline Solution (Drug)
结局指标
主要结局
Hair Regrowth: SALT Score
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Safety End Point: Adverse Events(Screening to Week 12)
- Liver Function: Alanine transaminase (ALT), Aspartate transaminase (AST), Alkaline phosphatase (ALP) measured in units per liter (U/L)(Week 0 to Week 12)
- Kidney Function: Blood Urea Nitrogen (BUN) and Creatinine measured in milligrams per deciliter (mg/dL)(Week 0 to Week 12)
- Number of participants with abnormal Complete Blood Count (CBC)(Week 0 to Week 12)
- Cyclosporine levels measured in nanograms per milliliter (ng/mL)(Week 0 to Week 12)
- Blood Pressure measured in millimeters of mercury (mm Hg)(Screening to Week 12)
- Heart Rate measured in beats per minute (b/m)(Screening to Week 12)
- Temperature measured in Fahrenheit (F)(Screening to Week 12)