Tirzepatide for Treatment of CCCA
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Central Centrifugal Cicatricial Alopecia Clinical Activity Tool Score
研究概览
简要总结
The goal of this pilot clinical trial is to learn if tirzepatide can treat active central centrifugal cicatricial alopecia (CCCA), a type of permanent scarring hair loss, in adults. The main questions it aims to answer are:
- Does tirzepatide improve the symptoms and signs of active CCCA?
- Does tirzepatide change the activity of genes in the scalp, especially genes related to scarring?
- Does tirzepatide promote hair regrowth?
Participants will:
- Inject tirzepatide once a week for 12 months.
- Visit the clinic for scalp examinations, photographs, and other health assessments.
- Have scalp biopsies at the beginning of the study and after 6 months of treatment.
- Have blood tests and other safety monitoring during the study.
There is no separate comparison group. Researchers will compare each participant's results during treatment with the participant's results at the beginning of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label pilot study. No participants, care providers, investigators, or outcomes assessors are formally masked to the intervention.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80 years.
- •Clinical and/or biopsy-confirmed diagnosis of central centrifugal cicatricial alopecia (CCCA).
- •Active CCCA, defined as a C-CAT disease activity score greater than
- •No treatment for CCCA during the 6 weeks before enrollment.
- •Able and willing to complete the study and follow all study procedures.
- •Managed by a Johns Hopkins dermatologist throughout the study.
排除标准
- •Currently taking an oral or systemic blood glucose-lowering medication.
- •Currently taking another medication for weight loss.
- •Hemoglobin A1C below 5.4%.
- •Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) score below
- •Body mass index below 19 kg/m².
- •Pregnant, breastfeeding, or planning a pregnancy.
- •Personal or family history of medullary thyroid cancer.
- •Personal or family history of multiple endocrine neoplasia type
- •History of chronic kidney disease.
- •History of pancreatitis.
- •History of diabetic retinopathy.
- •Severe gastrointestinal disease.
- •Recent or planned major surgery.
- •Type 1 diabetes.
- •Any other contraindication to tirzepatide.
- •History of keloids or hypertrophic scarring.
- •History of poor wound healing.
- •History of a blood-clotting disorder.
- •Allergy to lidocaine or epinephrine.
- •Known sensitivity to local numbing medication.
- •Any significant medical condition that the investigator believes would make participation unsafe or prevent completion of the study.
研究组 & 干预措施
Tirzepatide Treatment
Participants will self-administer tirzepatide by subcutaneous injection once weekly for 12 months. Tirzepatide will be administered at 2.5 mg once weekly for the first 4 weeks, followed by 5 mg once weekly for the remainder of the study. Participants may use topical corticosteroids as needed for intolerable CCCA-related symptoms, such as scalp pain or itching.
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Change in Central Centrifugal Cicatricial Alopecia Clinical Activity Tool Score
时间窗: Baseline, 3 months, 6 months
Disease activity will be measured using the Central Centrifugal Cicatricial Alopecia Clinical Activity Tool (C-CAT). The C-CAT assesses disease progression, scalp pain or tenderness, scalp itching, inflammation, and scalp fibrosis. Total scores range from 0 to 10, with higher scores indicating greater disease activity. Scores obtained during treatment will be compared with the baseline score.
Change in Scalp Gene-Expression Profiles
时间窗: Baseline, 6 months
Differential messenger RNA expression will be assessed using bulk RNA sequencing of paired scalp biopsies collected at baseline and 6 months of tirzepatide treatment. Differential expression will be defined as at least a two-fold change with an adjusted p-value less than 0.05. Analyses will focus on profibrotic and inflammatory pathways, including transforming growth factor beta, collagens 1, 3, and 6A1, and T-helper 17-related pathways.
次要结局
- Change in Central Hair Loss Grade(Baseline, 3 months, 6 months)
- Physician Global Assessment of Change in Hair Loss(Baseline, 3 months, 6 months)