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.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
Contactos e Locais
Contato de estudo
- Nome: Dakarai A Dunbar, BS
- Número de telefone: 4435976380
- E-mail: ddunbar7@jh.edu
Estude backup de contato
- Nome: Crystal U Aguh, M.D.
- E-mail: cagi1@jhmi.edu
Locais de estudo
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Maryland
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Baltimore, Maryland, Estados Unidos, 21287
- Recrutamento
- Johns Hopkins Outpatient Center
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Contato:
- Dakarai Dunbar, B.S.
- Número de telefone: 443-597-6380
- E-mail: ddunbar7@jh.edu
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Columbia, Maryland, Estados Unidos, 21044
- Recrutamento
- Medical Pavilion at Howard County
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Contato:
- Dakarai Dunbar, B.S.
- Número de telefone: 443-597-6380
- E-mail: ddunbar7@jh.edu
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Central Centrifugal Cicatricial Alopecia Clinical Activity Tool Score
Prazo: 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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Central Hair Loss Grade
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Crystal U Aguh, M.D., The Johns Hopkins Department of Dermatology
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Condições Patológicas, Anatômicas
- Doenças Metabólicas
- Distúrbios do Metabolismo da Glicose
- Doenças de pele
- Hiperinsulinismo
- Hipotricose
- Doenças do cabelo
- Condições Patológicas, Sinais e Sintomas
- Doenças Nutricionais e Metabólicas
- Doenças da Pele e do Tecido Conjuntivo
- Alopecia
- Resistência a insulina
- Aminoácidos, peptídeos e proteínas
- Proteínas
- Receptor peptídeo 1 do tipo glucagon
- Receptores peptídicos semelhantes a glucagon
- Receptores, acoplado à proteína G.
- Receptores, superfície celular
- Proteínas da membrana
- Receptores, hormônio gastrointestinal
- Receptores, peptídeo
- Tirzepatide
Outros números de identificação do estudo
- IRB00543694
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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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