[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647058":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":10,"locations":10,"responsibleParty":29,"collaborators":10,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":10,"eligibilityCriteria":37,"healthyVolunteers":33,"sex":38,"minAge":39,"maxAge":10,"enrollmentInfo":40,"targetDuration":10,"studyType":43,"phases":10,"briefSummary":44,"conditions":45,"keywords":10,"overallStatus":48,"whyStopped":10,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":10},{"fullName":5,"class":6},"Hanson Medical, Inc.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Recent Scar",null,"Patients at risk of developing a hypertrophic or keloid scar, aged 3 years and older.",[13,14],"Device: Dermatix","Device: Dermatix Ultra",{"label":16,"type":10,"description":17,"interventionNames":18},"Older Scars","Patients with existing scars, aged 3 years and older,",[13,14],[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DEVICE","Dermatix","Patients will be supplied with two 15g tubes of Dermatix at Visit 1 - Baseline Visit with the clinician, which will be sufficient to last the duration of the study (6-months) when applied as instructed (i.e. twice daily). If for any reason the patient runs out of the investigational product, a contingency supply will be in place and patients will be supplied with an additional tube. Patients will also be provided with the IFU of the supplied device and the clinician will provide instructions as to the application, frequency, and duration of use of the device (i.e. applied topically to the scar, twice daily for 6 months\u002Funtil final study visit).",[16,9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"Dermatix Ultra","Patients will be supplied with two 15g tubes of Dermatix Ultra at Visit 1 - Baseline Visit with the clinician, which will be sufficient to last the duration of the study (6-months) when applied as instructed (i.e. twice daily). If for any reason the patient runs out of the investigational product, a contingency supply will be in place and patients will be supplied with an additional tube. Patients will also be provided with the IFU of the supplied device and the clinician will provide instructions as to the application, frequency, and duration of use of the device (i.e. applied topically to the scar, twice daily for 6 months\u002Funtil final study visit).",[16,9],{"type":30,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100647058","scar-gel-product-family-clinical-investigation-100647058",false,"NCT07684573","Scar Gel Product Family Clinical Investigation","PMCF Investigation to Compare the Clinical Performance\u002FBenefit of Dermatix With Dermatix Ultra","Inclusion Criteria:\n\n* Patients aged \\>3 years.\n* Patients with keloids and hypertrophic scars (such as those resulting from general surgical procedures, trauma wounds, and burns), i.e., older scars.\n* Patients at risk of developing keloids and hypertrophic scars, i.e., recent scars.\n\nExclusion Criteria:\n\n* Patients with unhealed and\u002For open wounds.\n* Patients with allergies to any of the ingredients.\n* Pregnant or breastfeeding women.\n* Patients using other topical skin treatments on\u002Faround the scar area.","ALL","3 Years",{"count":41,"type":42},150,"ESTIMATED","OBSERVATIONAL","The purpose of this PMCF investigation is to determine whether there are differences between the two formulations (Dermatix and Dermatix Ultra) in improving keloid and hypertrophic scars clinical symptoms and in the overall scar perception (including scar appearance and treatment perception).\n\nThis PMCF investigation has been designed to address the conclusions of the latest CER \\[PDPROJ-4-CE-R\\] and the objectives. It has been chosen as an appropriate activity as it enables the collection of device-specific data on both device formulations and on the entire intended population. Moreover, the design of the PMCF investigation (single-center, parallel, open-label, two-arm, randomized controlled study) enables the direct comparison of the clinical performance\u002Fbenefit between the two formulations.",[46,47],"Hypertrophic Scars","Keloids","NOT_YET_RECRUITING","2026-06-29",{"date":51,"type":52},"2026-07-06","ACTUAL",{"date":54,"type":42},"2026-07",{"date":56,"type":42},"2026-12",{"name":5,"class":6}]