Recruiting
Phase 2

Tirzepatide

Sponsor:

Johns Hopkins University

Code:

NCT07734870

Conditions

Central Centrifugal Cicatricial Alopecia (CCCA)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tirzepatide

Study Details

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

Central Centrifugal Cicatricial Alopecia (CCCA)

Study ID

NCT07734870

Start date

Sep 15, 2026

Status verified date

Sep, 2026

Completion date

May 25, 2028

Anticipated

Primary completion date

May 25, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Tirzepatide

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 outcome measure

  • Change in Central Centrifugal Cicatricial Alopecia Clinical Activity Tool Score [ Time Frame: Baseline, 3 months, 6 months ]
  • Change in Scalp Gene-Expression Profiles [ Time Frame: Baseline, 6 months ]

Central Contacts and Locations

Central contacts

Dakarai A Dunbar, BS

4435976380ddunbar7@jh.edu

Crystal U Aguh, M.D.

cagi1@jhmi.edu

Locations

Johns Hopkins Outpatient Center

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Dakarai Dunbar, B.S.

443-597-6380ddunbar7@jh.edu

Medical Pavilion at Howard County

Recruiting

Columbia, Maryland, United States, 21044

Contacts

Dakarai Dunbar, B.S.

443-597-6380ddunbar7@jh.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Sep 23, 2026

Last verified

Sep, 2026

Keywords

  • Scarring alopecia
  • Hair loss
  • Hair regrowth
  • Scalp fibrosis
  • Tirzepatide
  • Metabolic dysfunction
  • Insulin Resistance
  • Gene expression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-09-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.