Tirzepatide for Treatment of CCCA
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 2
Contatti e Sedi
Contatto studio
- Nome: Dakarai A Dunbar, BS
- Numero di telefono: 4435976380
- Email: ddunbar7@jh.edu
Backup dei contatti dello studio
- Nome: Crystal U Aguh, M.D.
- Email: cagi1@jhmi.edu
Luoghi di studio
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Maryland
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Baltimore, Maryland, Stati Uniti, 21287
- Reclutamento
- Johns Hopkins Outpatient Center
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Contatto:
- Dakarai Dunbar, B.S.
- Numero di telefono: 443-597-6380
- Email: ddunbar7@jh.edu
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Columbia, Maryland, Stati Uniti, 21044
- Reclutamento
- Medical Pavilion at Howard County
-
Contatto:
- Dakarai Dunbar, B.S.
- Numero di telefono: 443-597-6380
- Email: ddunbar7@jh.edu
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Tirzepatide Treatment
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. |
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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Central Centrifugal Cicatricial Alopecia Clinical Activity Tool Score
Lasso di tempo: 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. |
Baseline, 3 months, 6 months
|
|
Change in Scalp Gene-Expression Profiles
Lasso di tempo: 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. |
Baseline, 6 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Central Hair Loss Grade
Lasso di tempo: 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. |
Baseline, 3 months, 6 months
|
|
Physician Global Assessment of Change in Hair Loss
Lasso di tempo: 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). |
Baseline, 3 months, 6 months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Crystal U Aguh, M.D., The Johns Hopkins Department of Dermatology
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Condizioni patologiche, anatomiche
- Malattie metaboliche
- Disturbi del metabolismo del glucosio
- Malattie della pelle
- Iperinsulinismo
- Ipotricosi
- Malattie dei capelli
- Condizioni patologiche, segni e sintomi
- Malattie nutrizionali e metaboliche
- Malattie della pelle e del tessuto connettivo
- Alopecia
- Resistenza all'insulina
- Aminoacidi, peptidi e proteine
- Proteine
- Recettore peptide-1 simile al glucagone
- Recettori peptidici simili al glucagone
- Recettori, accoppiati a g-proteina
- Recettori, superficie cellulare
- Proteine della membrana
- Recettori, ormone gastrointestinale
- Recettori, peptide
- Tirzepatide
Altri numeri di identificazione dello studio
- IRB00543694
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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.
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