Central Centrifugal Cicatricial Alopecia (CCCA)
Conditions
Keywords
Scarring alopecia, Hair loss, Hair regrowth, Scalp fibrosis, Tirzepatide, Metabolic dysfunction, Insulin Resistance, Gene expression
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.
Interventions
DRUGTirzepatide
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.
Sponsors
Johns Hopkins University
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label pilot study. No participants, care providers, investigators, or outcomes assessors are formally masked to the intervention.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Central Centrifugal Cicatricial Alopecia Clinical Activity Tool Score | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Central Hair Loss Grade | 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 | 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). |
Countries
United States
Contacts
CONTACTDakarai A Dunbar, BS
CONTACTCrystal U Aguh, M.D.
PRINCIPAL_INVESTIGATORCrystal U Aguh, M.D.
The Johns Hopkins Department of Dermatology
Outcome results
None listed