Tirzepatide for Treatment of CCCA

Обзор

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.

Вмешательства

• Препарат Tirzepatide
  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.

Первичные конечные точки

• Change in Central Centrifugal Cicatricial Alopecia Clinical Activity Tool Score [Срок оценки: Baseline, 3 months, 6 months]
• Change in Scalp Gene-Expression Profiles [Срок оценки: Baseline, 6 months]

Вторичные конечные точки (2)

• Change in Central Hair Loss Grade [Срок оценки: Baseline, 3 months, 6 months]
• Physician Global Assessment of Change in Hair Loss [Срок оценки: Baseline, 3 months, 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Johns Hopkins Outpatient Center — Baltimore
• Medical Pavilion at Howard County — Columbia

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 33609590

Идентификаторы

NCT: NCT07734870 · IRB00543694

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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