Tirzepatide for Central Centrifugal Alopecia

Not yet recruiting at 1 trial location
DA
CU
Overseen ByCrystal U Aguh, M.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether tirzepatide, a medication, can treat central centrifugal cicatricial alopecia (CCCA), a condition where scarring on the scalp causes hair loss. Researchers aim to determine if this medication improves symptoms, affects gene activity related to scarring, and promotes hair regrowth. Participants will inject tirzepatide weekly for a year and undergo scalp checks and tests. It suits adults with an active diagnosis of CCCA who haven’t received treatment for it in the past six weeks. As a Phase 2 trial, this research measures how well tirzepatide works in an initial, smaller group, offering participants a chance to contribute to important findings.

Is there any evidence suggesting that tirzepatide is likely to be safe for humans?

Research has shown that tirzepatide is generally safe for people. This medication is being tested for various health conditions and is already FDA-approved for treating type 2 diabetes, indicating its safety when used correctly. In earlier studies on diabetes, common side effects included mild to moderate stomach issues, such as nausea or diarrhea, which typically improved over time.

For treating central centrifugal cicatricial alopecia (CCCA), tirzepatide is initially administered at a lower dose, potentially reducing side effects. Participants experiencing scalp discomfort can use special creams to enhance comfort and safety.

Overall, while all medications carry some risks, tirzepatide appears to have a manageable safety profile based on current research. Regular check-ups during the study allow for the prompt addressing of any concerns.12345

Why are researchers excited about this possible treatment for alopecia?

Unlike the standard treatments for Central Centrifugal Cicatricial Alopecia (CCCA), which typically involve topical corticosteroids or oral antibiotics, tirzepatide offers a novel approach by targeting metabolic pathways. Tirzepatide is a GLP-1 receptor agonist, originally developed for diabetes and obesity management, which is thought to have potential benefits in treating CCCA by improving blood circulation and reducing inflammation in the scalp. Researchers are excited about tirzepatide because its unique mechanism could address the underlying causes of CCCA rather than just alleviating symptoms. Additionally, its once-weekly injection could offer a more convenient option compared to daily topical treatments.

What evidence suggests that tirzepatide might be an effective treatment for CCCA?

Research has shown that tirzepatide might help treat central centrifugal cicatricial alopecia (CCCA), a type of permanent hair loss. In studies with drugs similar to tirzepatide, about 58% of patients experienced improvements, including reduced scalp inflammation and some hair regrowth. This trial aims to evaluate tirzepatide's potential to address hair loss and reduce scarring by working in similar ways. Although direct evidence for tirzepatide specifically in CCCA is limited, these early signs offer encouragement for those considering participation in this trial.12367

Who Is on the Research Team?

CU

Crystal U Aguh, M.D.

Principal Investigator

The Johns Hopkins Department of Dermatology

Are You a Good Fit for This Trial?

This trial is for adults with active central centrifugal cicatricial alopecia (CCCA), a type of scarring hair loss. Participants should be willing to use tirzepatide injections, attend regular clinic visits, and undergo scalp biopsies and blood tests.

Inclusion Criteria

I have active CCCA with a disease activity score above 1.
I am between 18 and 80 years old.
Able and willing to complete the study and follow all study procedures
See 3 more

Exclusion Criteria

Hemoglobin A1C below 5.4%
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) score below 2
Body mass index below 19 kg/m²
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants self-administer tirzepatide by subcutaneous injection once weekly for 12 months. Tirzepatide is 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.

12 months
Regular clinic visits for scalp examinations, photographs, and health assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including scalp biopsies and blood tests.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Tirzepatide

Trial Overview

The study is testing weekly self-injections of tirzepatide over 12 months to see if it can improve symptoms of CCCA, affect gene activity in the scalp, or help regrow hair. Each participant's progress will be compared to their own starting point; there is no separate control group.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Tirzepatide TreatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborator

Trials
578
Recruited
33,600+

Eli Lilly and Company

Industry Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

NCT07734870 | Tirzepatide for Treatment of CCCA

Total scores range from 0 to 10, with higher scores indicating greater disease activity. 3 months, 6 months change. Scores range from 0 to 5, ...

GLP-1 agonists may modulate treatment efficacy in central ...

Of the 160 adults with CCCA on GLP1As, 81 (50.6%) met inclusion criteria, 47 (58.0%) of which were responders and 34 (42.0%) of which were nonresponders. There ...

GLP-1 Agonists May Modulate Treatment Efficacy in ...

Patients were classified as responders based on improvement in scalp inflammation, scalp symptoms, or hair regrowth at follow-up visits.

Tirzepatide for Treatment of CCCA | Clinical Trial

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.

Tirzepatide for Treatment of CCCA - ClinicalTrials.Veeva

The goal of this pilot clinical trial is to learn if tirzepatide can treat active central centrifugal cicatricial alopecia (CCCA), a type of ...

Tirzepatide for Active CCCA Hair Loss

The study seeks to understand if tirzepatide can improve the symptoms and signs of active CCCA, alter the activity of genes in the scalp ...

A Review of the Clinical Trial Landscape

Central Centrifugal Cicatricial Alopecia (CCCA) is an irreversible primary scarring alopecia impacting up to 5.6% of Black women with significant diagnostic