[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07734870":3,"trial-entities:NCT07734870":164,"trial-summary:NCT07734870":168},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":45,"secondary_outcomes":54,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":14,"eligibility_criteria":64,"std_ages":95,"locations":98,"central_contacts":123,"overall_officials":130,"references":134,"see_also_links":163},"NCT07734870","IRB00543694","Tirzepatide for Treatment of CCCA","NOT_YET_RECRUITING","2028-05-25","2026-07","2026-07-29","2026-08-23","Johns Hopkins University","OTHER",false,"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:\n\n* Does tirzepatide improve the symptoms and signs of active CCCA?\n* Does tirzepatide change the activity of genes in the scalp, especially genes related to scarring?\n* Does tirzepatide promote hair regrowth?\n\nParticipants will:\n\n* Inject tirzepatide once a week for 12 months.\n* Visit the clinic for scalp examinations, photographs, and other health assessments.\n* Have scalp biopsies at the beginning of the study and after 6 months of treatment.\n* Have blood tests and other safety monitoring during the study.\n\nThere 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.",null,[18],"Central Centrifugal Cicatricial Alopecia (CCCA)",[20,21,22,23,24,25,26,27],"Scarring alopecia","Hair loss","Hair regrowth","Scalp fibrosis","Tirzepatide","Metabolic dysfunction","Insulin Resistance","Gene expression","INTERVENTIONAL","TREATMENT",[31],"PHASE2",{"count":33,"type":34},20,"ESTIMATED",[36],{"type":37,"name":24,"description":38,"armGroupLabels":39,"otherNames":41},"DRUG","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.",[40],"Tirzepatide Treatment",[42,43,44],"Mounjaro","Zepbound","LY3298176",[46,50],{"measure":47,"description":48,"timeFrame":49},"Change in Central Centrifugal Cicatricial Alopecia Clinical Activity Tool Score","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",{"measure":51,"description":52,"timeFrame":53},"Change in Scalp Gene-Expression Profiles","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",[55,58],{"measure":56,"description":57,"timeFrame":49},"Change in Central Hair Loss Grade","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.",{"measure":59,"description":60,"timeFrame":49},"Physician Global Assessment of Change in Hair Loss","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).","ALL","18 Years","80 Years",{"inclusion":65,"exclusion":72,"raw_text":94},[66,67,68,69,70,71],"Age 18 to 80 years.","Clinical and\u002For 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.",[73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93],"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\u002Fm².","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.","Inclusion Criteria:\n\n* Age 18 to 80 years.\n* Clinical and\u002For biopsy-confirmed diagnosis of central centrifugal cicatricial alopecia (CCCA).\n* Active CCCA, defined as a C-CAT disease activity score greater than 1.\n* No treatment for CCCA during the 6 weeks before enrollment.\n* Able and willing to complete the study and follow all study procedures.\n* Managed by a Johns Hopkins dermatologist throughout the study.\n\nExclusion Criteria:\n\n* Currently taking an oral or systemic blood glucose-lowering medication.\n* Currently taking another medication for weight loss.\n* Hemoglobin A1C below 5.4%.\n* Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) score below 2.\n* Body mass index below 19 kg\u002Fm².\n* Pregnant, breastfeeding, or planning a pregnancy.\n* Personal or family history of medullary thyroid cancer.\n* Personal or family history of multiple endocrine neoplasia type 2.\n* History of chronic kidney disease.\n* History of pancreatitis.\n* History of diabetic retinopathy.\n* Severe gastrointestinal disease.\n* Recent or planned major surgery.\n* Type 1 diabetes.\n* Any other contraindication to tirzepatide.\n* History of keloids or hypertrophic scarring.\n* History of poor wound healing.\n* History of a blood-clotting disorder.\n* Allergy to lidocaine or epinephrine.\n* Known sensitivity to local numbing medication.\n* Any significant medical condition that the investigator believes would make participation unsafe or prevent completion of the study.",[96,97],"ADULT","OLDER_ADULT",[99,114],{"facility":100,"city":101,"state":102,"zip":103,"country":104,"contacts":105,"geoPoint":111},"Johns Hopkins Outpatient Center","Baltimore","Maryland","21287","United States",[106],{"name":107,"role":108,"phone":109,"email":110},"Dakarai Dunbar, B.S.","CONTACT","443-597-6380","ddunbar7@jh.edu",{"lat":112,"lon":113},39.29038,-76.61219,{"facility":115,"city":116,"state":102,"zip":117,"country":104,"contacts":118,"geoPoint":120},"Medical Pavilion at Howard County","Columbia","21044",[119],{"name":107,"role":108,"phone":109,"email":110},{"lat":121,"lon":122},39.24038,-76.83942,[124,127],{"name":125,"role":108,"phone":126,"email":110},"Dakarai A Dunbar, BS","4435976380",{"name":128,"role":108,"email":129},"Crystal U Aguh, M.D.","cagi1@jhmi.edu",[131],{"name":128,"affiliation":132,"role":133},"The Johns Hopkins Department of Dermatology","PRINCIPAL_INVESTIGATOR",[135,139,142,145,148,151,154,157,160],{"pmid":136,"type":137,"citation":138},"40771443","BACKGROUND","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\u002F000544777. Epub 2025 Feb 20.",{"pmid":140,"type":137,"citation":141},"29282458","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\u002Fjamadermatol.2017.5163.",{"pmid":143,"type":137,"citation":144},"38856224","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\u002FNEJMoa2401943. Epub 2024 Jun 8.",{"pmid":146,"type":137,"citation":147},"39230880","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\u002Fjamadermatol.2024.3062.",{"pmid":149,"type":137,"citation":150},"33378699","Tuleta I, Frangogiannis NG. Diabetic fibrosis. Biochim Biophys Acta Mol Basis Dis. 2021 Apr 1;1867(4):166044. doi: 10.1016\u002Fj.bbadis.2020.166044. Epub 2020 Dec 28.",{"pmid":152,"type":137,"citation":153},"29913259","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\u002Fj.jaad.2018.05.1257. Epub 2018 Jun 18.",{"pmid":155,"type":137,"citation":156},"35007355","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\u002Fexd.14524. Epub 2022 Jan 20.",{"pmid":158,"type":137,"citation":159},"33609590","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\u002Fj.jaad.2021.02.036. Epub 2021 Feb 18. No abstract available.",{"pmid":161,"type":137,"citation":162},"24680004","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\u002Fj.det.2013.12.005. Epub 2014 Jan 22.",[],{"nct_id":4,"conditions":165,"biomarkers":167},[166],"Central centrifugal cicatricial alopecia",[],{"nct_id":4,"found":169,"summary":170,"prompt_version":180},true,{"design":171,"status":172,"heading":173,"summary":174,"follow_up":175,"word_count":176,"commitments":177,"compensation":178,"drugs_mentioned":179},"This is an interventional pilot study with 20 participants. There is no separate comparison group.","completed","Tirzepatide for Central Centrifugal Cicatricial Alopecia (CCCA)","This study is testing if a medication called tirzepatide can help adults with active Central Centrifugal Cicatricial Alopecia (CCCA), a type of permanent hair loss that causes scarring. Researchers want to see if tirzepatide improves the signs and symptoms of CCCA, changes how genes in the scalp behave (especially those linked to scarring), and helps hair regrow. You might be able to join if you are 18-80 years old, have a confirmed diagnosis of active CCCA, and haven't received CCCA treatment in the last 6 weeks. Participants will inject tirzepatide once a week for 12 months. The study will measure changes in your CCCA symptoms and scalp gene activity over 3 and 6 months. The current recruitment status is unclear.","The study measures changes in CCCA symptoms at 3 and 6 months, and scalp gene expression at 6 months.",120,"You would inject tirzepatide once a week for 12 months. You will have clinic visits for exams, photos, and other health checks, including scalp biopsies at the start and after 6 months, and blood tests for safety.","Not stated in the trial record.",[24],"v2"]