NCT07734870 · Johns Hopkins University
Tirzepatide for Treatment of CCCA
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.
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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.
Interventions
DRUG
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 measures
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Baltimore, Maryland
- Columbia, Maryland
Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Eli Lilly and Company
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 23, 2026 · Source of record for eligibility and locations