Current partner codePEPTIDESDE
NCT07734870·Phase 2·INTERVENTIONAL

Tirzepatide for Treatment of CCCA

Status

Not yet recruiting

Phase

Phase 2

Enrollment

20

Locations

2

Results

Not posted

Publications

9

Study summary

What the protocol is testing.

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

Treatment arms and agents.

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.

Timeline

From registration to results.

  1. First posted

    Jul 29, 2026

  2. Study start

    Aug 23, 2026

  3. Primary completion

    May 25, 2028

  4. Study completion

    May 25, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Jul 29, 2026

Outcomes

What the study measures.

Primary outcomes

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.

Secondary outcomes

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.

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).

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
80 Years
Sex
ALL
Healthy volunteers
No

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 locations

2 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Johns Hopkins Outpatient Center

Baltimore, Maryland, United States

Medical Pavilion at Howard County

Columbia, Maryland, United States

Publications

Results and literature.

PMID 40771443Qadri A, Will E, Aguh C. Using Disease Symptomatology to Guide Treatment in Patients with Central Centrifugal Cicatricial Alopecia: Introduction of C-CAT Scoring Tool. Skin Appendage Disord. 2025 Aug;11(4):309-315. doi: 10.1159/000544777. Epub 2025 Feb 20.PMID 29282458Dina Y, Okoye GA, Aguh C. Association of Uterine Leiomyomas With Central Centrifugal Cicatricial Alopecia. JAMA Dermatol. 2018 Feb 1;154(2):213-214. doi: 10.1001/jamadermatol.2017.5163.PMID 38856224Loomba R, Hartman ML, Lawitz EJ, Vuppalanchi R, Boursier J, Bugianesi E, Yoneda M, Behling C, Cummings OW, Tang Y, Brouwers B, Robins DA, Nikooie A, Bunck MC, Haupt A, Sanyal AJ; SYNERGY-NASH Investigators. Tirzepatide for Metabolic Dysfunction-Associated Steatohepatitis with Liver Fibrosis. N Engl J Med. 2024 Jul 25;391(4):299-310. doi: 10.1056/NEJMoa2401943. Epub 2024 Jun 8.PMID 39230880Bao A, Qadri A, Gadre A, Will E, Collins D, Ahima R, Bordone LA, Aguh C. Low-Dose Metformin and Profibrotic Signature in Central Centrifugal Cicatricial Alopecia. JAMA Dermatol. 2024 Nov 1;160(11):1211-1219. doi: 10.1001/jamadermatol.2024.3062.PMID 33378699Tuleta I, Frangogiannis NG. Diabetic fibrosis. Biochim Biophys Acta Mol Basis Dis. 2021 Apr 1;1867(4):166044. doi: 10.1016/j.bbadis.2020.166044. Epub 2020 Dec 28.PMID 29913259Aguh C, Dina Y, Talbot CC Jr, Garza L. Fibroproliferative genes are preferentially expressed in central centrifugal cicatricial alopecia. J Am Acad Dermatol. 2018 Nov;79(5):904-912.e1. doi: 10.1016/j.jaad.2018.05.1257. Epub 2018 Jun 18.PMID 35007355Jamerson TA, Conover Talbot C Jr, Dina Y, Kwatra SG, Garza LA, Aguh C. Gene expression profiling suggests severe, extensive central centrifugal cicatricial alopecia may be both clinically and biologically distinct from limited disease subtypes. Exp Dermatol. 2022 May;31(5):789-793. doi: 10.1111/exd.14524. Epub 2022 Jan 20.PMID 33609590Roche FC, Harris J, Ogunleye T, Taylor SC. Association of type 2 diabetes with central centrifugal cicatricial alopecia: A follow-up study. J Am Acad Dermatol. 2022 Mar;86(3):661-662. doi: 10.1016/j.jaad.2021.02.036. Epub 2021 Feb 18. No abstract available.PMID 24680004Ogunleye TA, McMichael A, Olsen EA. Central centrifugal cicatricial alopecia: what has been achieved, current clues for future research. Dermatol Clin. 2014 Apr;32(2):173-81. doi: 10.1016/j.det.2013.12.005. Epub 2014 Jan 22.

Primary links

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