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NCT07734870

Overview

NCT ID: NCT07734870
Lead Sponsor: Johns Hopkins UniversityOTHER
Official Title: Tirzepatide for Treatment of CCCA
Brief Summary: 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.
Conditions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 29, 2026Actual
Start Date: Aug 23, 2026Estimated
Primary Completion Date: May 25, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility 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.

Study Plan

Study Type: Interventional
Phase: Phase 2
Enrollment: 20Estimated
Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Dakarai A Dunbar, BSContact
ddunbar7@jh.edu4435976380

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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