Tirzepatide for Treatment of CCCA

Johns Hopkins University

Status and phase: Enrolling; Phase 2

Conditions: Central Centrifugal Cicatricial Alopecia (CCCA)

Treatments: Drug: Tirzepatide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07734870

IRB00543694

Details and patient eligibility

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Tirzepatide Treatment

Experimental group

Description:

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.

Treatment:

Drug: Tirzepatide