[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611372":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":30,"locations":36,"responsibleParty":52,"collaborators":24,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":24,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":78,"whyStopped":24,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Cosmetique Active International","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LASER","EXPERIMENTAL","Healthy participants aged between 35 and 70 years old with presence of at least two solar lentigo on each hand or forearm, with each spot measuring less than 100 mm x 100 mm as assessed by the investigator",[13],"Other: LASER",{"label":15,"type":16,"description":11,"interventionNames":17},"LASER AND ACTIVE FLORMULA","ACTIVE_COMPARATOR",[18],"Combination Product: LASER AND ACTIVE FORMULA",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"OTHER","Application of laser once a weeks by dermatologist on spot and application of sunscreen twice a day ( morning and midday) for 3 months",[9],null,{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":24},"COMBINATION_PRODUCT","LASER AND ACTIVE FORMULA","application of laser once a week by dermatologist, active formula twice a day ( morning and evening) and sunscreen formula twice a day (morning and midday) for 3 months",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":24,"email":35},"Gitanjali PETKAR","CONTACT","(+230) 4012600","g.petkar@cidp-cro.com",[37],{"facility":38,"status":24,"city":39,"state":24,"zip":24,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"CIDP Ltée","Phoenix","Mauritius","MU",{"type":43,"coordinates":44},"Point",[45,46],57.50222,-20.28667,{"lat":46,"lon":45},[49],{"name":50,"role":33,"phone":24,"phoneExt":24,"email":51},"Dylan JODUN","d.jodun@cidp-cro.com",{"type":53,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100611372","clinical-investigation-to-evaluate-the-efficacy-and-safety-of-epilady-prototype-device-followed-by-application-of-a-topical-formula-on-depigmentation-of-lentigo-spots-100611372",false,"NCT07239726","CLINICAL INVESTIGATION TO EVALUATE THE EFFICACY AND SAFETY OF EPILADY PROTOTYPE DEVICE FOLLOWED BY APPLICATION OF A TOPICAL FORMULA ON DEPIGMENTATION OF LENTIGO SPOTS","CLINICAL INVESTIGATION TO EVALUATE THE EFFICACY AND SAFETY OF EPILADY PROTOTYPE DEVICE FOLLOWED BY APPLICATION OF A TOPICAL FORMULA ON DEPIGMENTATION OF LENTIGO SPOTS IN HEALTHY WOMEN PARTICIPANTS - STUDY UNDER DERMATOLOGICAL CONTROL","EPILADY","Inclusion Criteria:\n\n* Healthy female participants aged between 35 and 70 years old at the time of inclusion.\n* All Fitzpatrick skin phototypes (I to VI) are eligible; groups I-II and V-VI should include at least one participant per group.\n* Presence of at least two solar lentigo (dark spots) on each hand or forearm, with each spot measuring less than 100 mm x 100 mm as assessed by the investigator.\n* Participant has read, understood, and accepted the constraints of the clinical investigation.\n* Participant has provided written informed consent to participate in the clinical investigation.\n* Participant is able to understand the language used in the investigational site and comprehend the information provided.\n* Participants are cooperative and compliant, aware of the clinical investigation requirements and willing to adhere to the full duration of participation and follow-up visits, in line with the CIP requirements.\n* Women of childbearing potential must commit to using an effective contraceptive method throughout the clinical investigation period and for at least three months prior to the inclusion visit, with no changes during that time.\n\nExclusion Criteria:\n\n* • Participants with dry or sensitive skin, as assessed by the investigator.\n\n  * Participants who have used cosmetic products with exfoliating or astringent claims on the hands within 4 weeks prior to the baseline visit.\n  * Participants who have used any home-use or professional low-level laser therapy (LLLT) or have participated in clinical studies involving LLLT within the 6 months preceding the baseline visit\n  * History of light-induced seizures or chronic migraine disorders.\n  * History of photosensitivity or photoallergic reactions.\n  * Presence of underlying dermatological conditions on the hands\u002Fforearms that, in the opinion of the investigator, could interfere with the clinical investigation assessments.\n  * A family history of melanoma in first- or second-degree relatives (parents or grandparents).\n  * Presence of excessive moles, non-lentigo pigmented lesions, tattoos, scars, or irritated skin in the test area that could affect the validity of the investigation.\n  * History of surgical procedures involving the areas designated for treatment.\n  * Participants who have been exposed to or plan to be exposed to sunbathing or artificial UV sources (e.g., mountain sports, phototherapy, tanning salons) within 1 month before the clinical investigation start or during the clinical investigation period.\n  * Use of suntan or self-tanning products within the 2 weeks preceding the baseline visit.\n  * Change in cosmetic habits (e.g., moisturizers, skincare, shower gels) during the 2 weeks prior to baseline.\n  * Use of any medications, topical treatments, skincare products, or aesthetic procedures listed in the CIP without observing the required wash-out periods, or unwillingness\u002Finability to comply with those restrictions during the clinical investigation.\n  * Participant who cannot be contacted by telephone in case of emergency\n  * Participant in an exclusion period or participating in another biomedical research clinical investigation (self-reported)\n  * Intellectual\u002Fmental inability to follow clinical investigation instructions (if suspected) or incapacitation.\n  * Participants working for the contract research organization (CIDP) in charge of this clinical investigation.",true,"FEMALE","35 Years","70 Years",{"count":67,"type":68},44,"ESTIMATED","INTERVENTIONAL",[71],"NA","To assess the efficacy of the Epilady investigational device, used with and without a topical depigmenting formula, in reducing the appearance of lentigo spots on the hands and forearms of healthy female participants over an 84-day period",[74],"Solar Lentigo",[76,77],"solar lentigo,","Laser treatment","NOT_YET_RECRUITING","2025-11-16",{"date":81,"type":82},"2025-11-20","ACTUAL",{"date":84,"type":68},"2026-01-07",{"date":86,"type":68},"2026-05-08",{"name":5,"class":6},1]