[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555489":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":58,"collaborators":10,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":10,"studyType":74,"phases":10,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":42,"whyStopped":10,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Erasmus Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hydroxychloroquine (HCQ)",null,"HCQ is administered orally at a dosage of 400 mg daily.",[13],"Drug: Hydroxychloroquine",{"label":15,"type":10,"description":16,"interventionNames":17},"Methotrexate (MTX)","MTX is given at a dose of 15 mg per week, orally or subcutaneously. Additionally, folate supplementation is administered concurrently as part of standard care, with folate 10 mg\u002Fweek administered 24 hours after MTX intake.",[18],"Drug: Methotrexate",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DRUG","Hydroxychloroquine","HCQ (15) is administered orally at a dosage of 400 mg daily.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"Methotrexate","MTX (16) is given at a dose of 15 mg per week, orally or subcutaneously. Additionally, folate supplementation is administered concurrently as part of standard care, with folate 10 mg\u002Fweek administered 24 hours after MTX intake.",[15],[30],{"name":31,"affiliation":5,"role":32},"DirkJan Hijnen, MD, PhD","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":10,"email":38},"Mathias Willaert, MD","CONTACT","(010) 704 01 10","HEMLET@erasmusmc.nl",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Erasmus MC","RECRUITING","Rotterdam","South Holland","3015GD","Netherlands","NL",{"type":49,"coordinates":50},"Point",[51,52],4.47917,51.9225,{"lat":52,"lon":51},[55,56],{"name":35,"role":36,"phone":37,"phoneExt":10,"email":38},{"name":35,"role":57,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"type":32,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"DirkJan Hijnen","MD, PhD","100555489","the-effectiveness-of-hydroxychloroquine-versus-methotrexate-in-the-treatment-of-lichen-planopilaris-in-routine-clinical-care-a-patient-preference-trial-100555489",false,"NCT06512753","The Effectiveness of Hydroxychloroquine Versus Methotrexate in the Treatment of Lichen Planopilaris in Routine Clinical Care: a Patient Preference Trial","HEMLET","Inclusion Criteria:\n\n* Age of 18 years and older.\n* Diagnosed with LPP.\n* Willingness to provide informed consent for participation in the study.\n* No contraindications or known allergies to HCQ or MTX.\n\nExclusion Criteria:\n\n* Histopathological different diagnosis than LPP.\n* Inability to adhere to the study protocol, including medication intake, clinic visits, and questionnaire completion.\n* Patients who are ineligible for the HCQ arm (due to contraindications), are automatically included in the MTX arm.\n* Contraindications HCQ:\n\nretinopathy and\u002For maculopathy\n\nmyasthenia gravis\n\nbody weight less than 35 kg\n\nPatients who are ineligible for the MTX arm (due to contraindications), are automatically included in the HCQ arm.\n\n\\- Contraindications MTX:\n\nConception (both male and female) and lactation\n\nSevere kidney or liver dysfunction (fibrosis, cirrhosis) or alcohol abuse\n\nBone marrow hypoplasia, immunodeficiency\n\nAnemia, leukopenia, or thrombocytopenia\n\nPoor nutritional status (low albumin)\n\nHypersensitivity or allergy to MTX\n\nLung toxicity due to MTX or significant reduction in lung function.","ALL","18 Years","80 Years",{"count":72,"type":73},56,"ESTIMATED","OBSERVATIONAL","Rationale Lichen planopilaris (LPP) is a prevalent form of cicatricial alopecia, predominantly affecting women and causing irreversible hair loss. Hydroxychloroquine (HCQ) and methotrexate (MTX) are the most frequently used systemics for treatment of LPP in daily practice. Due to the absence of well-established treatment guidelines, this study aims to evaluate the effectiveness of HCQ and MTX in routine clinical care.\n\nObjective(s) To investigate the effectiveness of HCQ and MTX in the treatment of adults with lichen planopilaris in routine clinical care.\n\nStudy type Prospective, patient preference clinical trial with a duration up to 48 weeks in accordance with the routine clinical care guidelines.\n\nStudy population This study will include adults (≥18 years) diagnosed with LPP.\n\nMethods Patients will choose between HCQ and MTX treatment as in routine clinical care, receiving follow-up in accordance with standard clinical practices. They will not be randomized. The primary endpoint is the measurement of the Lichen Planopilaris Activity Index (LPPAI) at the 6-months, providing a quantitative assessment of the disease's activity and response to the selected treatment. The Skindex-29 questionnaire will be conducted at each visit, allowing evaluation of the impact on patients' quality of life.",[77,78],"Lichen Planopilaris","Cicatricial Alopecia",[80,81,22,26],"Lichen planopilaris","Cicatricial alopecia","2024-07-16",{"date":84,"type":85},"2024-07-22","ACTUAL",{"date":87,"type":85},"2024-07-01",{"date":89,"type":73},"2026-07-01",{"name":5,"class":6},1]