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NCT Number: NCT07734870

Tirzepatide for Treatment of CCCA

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.

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Key information

Conditions

Central Centrifugal Cicatricial Alopecia (CCCA) Alopecia Glucose Metabolism Disorders Hair Diseases Hyperinsulinism Hypotrichosis Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Johns Hopkins Outpatient Center, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Mounjaro, Zepbound, LY3298176

Primary outcomes

  1. Change in Central Centrifugal Cicatricial Alopecia Clinical Activity Tool Score

    Time frame: 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.

  2. Change in Scalp Gene-Expression Profiles

    Time frame: 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.

Secondary outcomes

  1. Change in Central Hair Loss Grade

    Time frame: Baseline, 3 months, 6 months

    Central scalp hair loss will be evaluated by physician raters using standardized clinical photographs and the Central Hair Loss Grade scale. Scores range from 0 to 5, with higher scores indicating more severe central hair loss. Scores obtained during treatment will be compared with the baseline score.

  2. Physician Global Assessment of Change in Hair Loss

    Time frame: Baseline, 3 months, 6 months

    Physician raters will compare standardized clinical photographs obtained at months 3 and 6 with baseline photographs. Change in hair loss will be evaluated using a 5-point physician global assessment scale. Score range 0 (None) - 4 (Very severe).

Study contacts

Contact information is provided by the study sponsor or research team.

Crystal U Aguh, M.D.

CONTACT

[email protected]

Dakarai A Dunbar, BS

CONTACT

[email protected]

4435976380

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Eli Lilly and Company
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 29, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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