Clinical trial

Tirzepatide for Treatment of CCCA

Opening soon · Phase 2 · 1 countries · Registry ID NCT07734870

Opening soonPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 80 Years

SexAll

Healthy volunteersNot accepted

ConditionCentral Centrifugal Cicatricial Alopecia (CCCA)

Full registry criteria

Inclusion Criteria: * 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 1. * 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. Exclusion Criteria: * 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 2. * 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 2. * 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.

Treatments and study arms

Tirzepatide

Drug

Tirzepatide solution will be self-administered by subcutaneous injection once weekly. Participants will receive 2.5 mg once weekly for the first 4 weeks, followed by 5 mg once weekly for the remainder of the 12-month treatment period. Injection sites will be rotated among the abdomen, thigh, or upper arm.

Primary outcomes

Change in Central Centrifugal Cicatricial Alopecia Clinical Activity Tool ScoreBaseline, 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 ProfilesBaseline, 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.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Johns Hopkins Outpatient Center🇺🇸 Baltimore, Maryland, United States

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Dakarai Dunbar, B.S.Contact

Email · Call 443-597-6380

Medical Pavilion at Howard County🇺🇸 Columbia, Maryland, United States

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Dakarai Dunbar, B.S.Contact

Email · Call 443-597-6380