Tirzepatide for Treatment of CCCA

NCT07734870 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: IRB00543694
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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)

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in Central Centrifugal Cicatricial Alopecia Clinical Activity Tool Score

  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.

  Baseline, 3 months, 6 months

• Change in Scalp Gene-Expression Profiles

  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.

  Baseline, 6 months

Secondary Outcomes (2)

• Change in Central Hair Loss Grade

  Baseline, 3 months, 6 months

• Physician Global Assessment of Change in Hair Loss

  Baseline, 3 months, 6 months

Study Arms (1)

Tirzepatide Treatment

EXPERIMENTAL

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.

Drug: Tirzepatide

Interventions

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.

Also known as: Mounjaro, Zepbound, LY3298176

Tirzepatide Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: collaborator
• Eli Lilly and Company: collaborator

Study Sites (2)

Johns Hopkins Outpatient Center

Baltimore, Maryland, 21287, United States

Location

Medical Pavilion at Howard County

Columbia, Maryland, 21044, United States

Location

Related Publications (9)

• Qadri 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: 40771443 BACKGROUND

• Dina 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: 29282458 BACKGROUND

• Loomba 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: 38856224 BACKGROUND

• Bao 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: 39230880 BACKGROUND

• Tuleta 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: 33378699 BACKGROUND

• Aguh 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: 29913259 BACKGROUND

• Jamerson 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: 35007355 BACKGROUND

• Roche 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: 33609590 BACKGROUND

• Ogunleye 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.

  PMID: 24680004 BACKGROUND

MeSH Terms

Conditions

Alopecia; Insulin Resistance

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Crystal U Aguh, M.D.

  The Johns Hopkins Department of Dermatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dakarai A Dunbar, BS

CONTACT

4435976380; ddunbar7@jh.edu

Crystal U Aguh, M.D.

CONTACT

cagi1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label pilot study. No participants, care providers, investigators, or outcomes assessors are formally masked to the intervention.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label, single-group pilot study in which all participants receive tirzepatide and serve as own controls. Clinical and molecular findings during treatment will be compared with baseline findings.

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): August 23, 2026
• Primary Completion (Estimated): May 25, 2028
• Study Completion (Estimated): May 25, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)