AzTrials
AzTrials

Central Centrifugal Cicatricial Alopecia (CCCA)Phase 2NCT07734870

Tirzepatide for Treatment of CCCA

A Phase 2 study testing Tirzepatide in people with Central Centrifugal Cicatricial Alopecia (CCCA), run by Johns Hopkins University at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Tirzepatide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesUnited States
Study dates
15 Sep 2026to 25 May 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 21Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dakarai A Dunbar, BS contact

4435976380

ddunbar7@jh.edu

Crystal U Aguh, M.D. contact

cagi1@jhmi.edu

United States2 sites, 2 recruiting

  • Johns Hopkins Outpatient Center

    Baltimore, Maryland, 21287

    Dakarai Dunbar, B.S., 443-597-6380, ddunbar7@jh.edu

    Recruiting

  • Medical Pavilion at Howard County

    Columbia, Maryland, 21044

    Dakarai Dunbar, B.S., 443-597-6380, ddunbar7@jh.edu

    Recruiting

Other trials in United States

About this study

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?
Read more

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.

Being tested
Tirzepatide
Keywords
Scarring alopecia, Hair loss, Hair regrowth, Scalp fibrosis, Tirzepatide, Metabolic dysfunction, Insulin Resistance, Gene expression
Medical subject headings
Alopecia, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TirzepatideDrug

    Also called Mounjaro, Zepbound, LY3298176

    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.

Study groups in NCT07734870
Study groupRoleWhat they receive
Tirzepatide TreatmentExperimentalParticipants 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.
Receives: Drug: Tirzepatide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 3 months, 6 months

  2. 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.

    Measured: Baseline, 6 months

Secondary outcomes (2)

  1. Change in Central Hair Loss Grade

    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.

    Measured: Baseline, 3 months, 6 months

  2. Physician Global Assessment of Change in Hair Loss

    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).

    Measured: Baseline, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2026
  2. Study start15 Sep 2026
  3. Primary completion25 May 2028 (estimated)
  4. Study completion25 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07734870
Sponsor's protocol ID
IRB00543694
Status last verified
Nov 2026
First submitted
24 Jul 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: There is no current plan to share individual participant data because of privacy and confidentiality considerations associated with the study's small sample size, clinical scalp photographs, and transcriptomic data. Study findings may be reported in aggregate in scientific presentations and publications.

Publications

  • 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.

    PubMed 40771443

  • 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.

    PubMed 29282458

  • 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.

    PubMed 38856224

  • 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.

    PubMed 39230880

  • 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.

    PubMed 33378699

  • 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.

    PubMed 29913259

  • 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.

    PubMed 35007355

  • 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.

    PubMed 33609590

  • 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.

    PubMed 24680004

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tirzepatide in people with Central Centrifugal Cicatricial Alopecia (CCCA), run by Johns Hopkins University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dakarai A Dunbar, BS (4435976380, ddunbar7@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Central Centrifugal Cicatricial Alopecia Clinical Activity Tool Score (time frame: Baseline, 3 months, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07734870, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in