[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658460":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":25,"studyPopulation":25,"armGroups":38,"interventions":57,"overallOfficials":25,"centralContacts":63,"locations":25,"responsibleParty":69,"collaborators":25,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":25,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":25,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":95,"whyStopped":25,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":101,"leadSponsor":103,"locationsCount":25},{"fullName":5,"class":6},"L'Oreal","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Transmission Electron Microscopy analyses","Transmission Electron Microscopy images will be acquired on the 3mm punch biopsies","24hours after Ultra Violet rays exposure",[14,17,21],{"measure":15,"description":16,"timeFrame":12},"Immunostaining with TOMM20 analyses","Immunostaining (TOMM20) images will be acquired with 3mm punch biopsies",{"measure":18,"description":19,"timeFrame":20},"Proteomic and Metabolomic analyses","Proteomic and Metabolomic analyses will be done trough tape stripping assessment.","24hours after Ultra Violet rays exposure versus baseline",{"measure":22,"description":23,"timeFrame":24},"pigmentation assessment","Skin pigmentation will be assessed through chromametric measurements and clinical scoring.","24h and one week after UV exposure versus baseline",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":29,"primaryPurpose":30,"observationalModel":25,"timePerspective":25,"maskingInfo":31},"RANDOMIZED","PARALLEL","Monocenter, double blind, randomized design, intra-individual comparison with four different product applied on the same participant.","TREATMENT",{"masking":32,"maskingDescription":25,"whoMasked":33},"QUADRUPLE",[34,35,36,37],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[39,45,49,53],{"label":40,"type":41,"description":42,"interventionNames":43},"Vehicle without UV","EXPERIMENTAL","Application of vehicle without any UVA1 exposure",[44],"Procedure: Skin biopsy",{"label":46,"type":41,"description":47,"interventionNames":48},"Vehicle with UV","Application of vehicle with a single 50J\u002Fcm2 UVA1 exposure",[44],{"label":50,"type":41,"description":51,"interventionNames":52},"Active without UV","Application of active with a single 50J\u002Fcm2 UVA1 exposure",[44],{"label":54,"type":41,"description":55,"interventionNames":56},"Active with UV","Application of active without UVA1 exposure",[44],[58],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":25},"PROCEDURE","Skin biopsy","3mm punch skin biopsies on four zones on the back of participant",[54,50,46,40],[64],{"name":65,"role":66,"phone":67,"phoneExt":25,"email":68},"de Dormael Romain, MsC","CONTACT","+33609556837","romain.dedormael@loreal.com",{"type":70,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100658460","skin-mitochondrial-protection-by-r0090948a-active-100658460",false,"NCT07853027","Skin Mitochondrial Protection by R0090948A Active","A Monocenter, Double-blind, Comparative, Controlled, Randomized Study to Evaluate the Effect of Active R0090948A at 1%, Compared to Vehicle, on Mitochondria With or Without UV Stress in Healthy Participants.","Inclusion Criteria:\n\n1. Women between 35 and 45 years old, both included\n2. Participant with skin phototype III according to Fitzpatrick classification\n3. Uniform skin color all over the four zones (difference in ITA° between the 4 zones should not be more than 4°)\n4. Average ITA° (Individual Typologic Angle calculated value) on the back over the four zones between 28° and 41° at screening \u002F inclusion visit\n5. Absence of freckles, naevi, hypo or hyper pigmented regions, hairs, marks of tanning and tatoo on the investigational area on the lower back\n6. Female of childbearing potential, who is not sexually active, or who is using an effective contraceptive method for at least one month before the beginning of the study, and throughout the study\n7. Female participant of childbearing potential or pre-menopausal woman (with absence of menstruations for less than one year) willing to undergo urine pregnancy test\n8. Participant with negative blood test results for Hepatitis B surface antigen (HBsAg), Hepatitis C antibodies (anti-HCV), and HIV, performed within 2 weeks prior to inclusion, with results documented in the participant's records.\n9. Participant accepting to undergo 4 biopsies (3mm diameter punch) on the back\n10. Participant willing and able to fulfill the study requirements and schedule\n11. Participant informed about the study objectives and procedures, and able to understand them\n12. Participant who has given written informed consent form\n\nExclusion Criteria:\n\n1. Participant who is pregnant or who is planning to become pregnant during the study\n2. Menopausal woman with absence of menstruation for more than one year\n3. Participant having changed hormonal treatment (contraception...) within the last 3 months or having to planned to change during the study\n4. Participant with bleeding disorders, bleeding with previous surgery and eventual use of drugs known to interfere with hemostasis which could impact on the biopsy collection\n5. Participant with positive results on at least one of the following viruses: Hepatitis B or Hepatitis C or HIV test.\n6. Any contra-indication for biopsies: medical history of allergy, hypersensitivity or any serious reaction to local anaesthesia, local antibiotic \\& antiseptic, history of healing defects (hypertrophy, keloids…)\n7. Having planned UV exposure of the investigational area (sunlight or sunbeds) throughout the study\n8. Having used sunbeds or excessive sun exposure of the investigational area within the 3 months before inclusion\n9. Having sunburn (erythema) on the back\n10. Dermatological disorders affecting the investigational area (presence of naevi, freckles, excess hair or uneven skin tones, vitiligo, photo-dermatological problems)\n11. History of skin cancer\n12. History of abnormal response to sun\n13. Presence of recent suntan (according to Investigator opinion) or photo-test marks\n14. Any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator\n15. Having used within the month before inclusion any systemic medication for more than 5 consecutive days (e.g. steroidal and non-steroidal anti-inflammatory drugs, corticoids, insulin, antihistamines, antihypertensive, antibiotics -e.g. quinolone, tetracycline, thiazides, fluoroquinolones-)\n16. Having used within the month before inclusion any medication known to cause abnormal responses to UV exposure (e.g. vitamin A derivatives, psoralen, aminolevulinic acid derivatives, etc.), or having planned to use these medications during the study\n17. Having used within the 3 months before inclusion any depigmenting \u002F whitening or pro-pigmenting topical treatments, or having planned to use these treatments during the study\n18. Having used, within the past 6 months, any physical treatment including laser or phototherapy (PUVA, IPL, PDT…) on the investigational area, or having planned to use these treatments during the study\n19. Having planned to perform intensive sport (\\> 5 hours per week) or swim during the study\n20. Participant who declares to be deprived of freedom by administrative or legal decision\n21. Participant who cannot be contacted by telephone in case of emergency\n22. Participant having participated within the 30 days before inclusion or currently participating in another clinical study","FEMALE","35 Years","45 Years",{"count":82,"type":83},13,"ESTIMATED","INTERVENTIONAL",[86],"NA","The study intends to evaluate the skin longevity through mitochondria protection efficacy of cosmetic products after 3 months of product application, under UV exposures or not, followed by skin biopsies.\n\nPrimary objective:\n\n\\- To assess the efficacy of the investigational active in skin mitochondria protection, after twelve weeks of product application with or without UV stress, by morphological and texture parameters measurements\n\nSecondary objectives:\n\n* To assess efficacy on other biomarkers of skin mitochondria with biopsies histological analyses\n* To assess efficacy by skin colorimetric measurements\n* To assess efficacy by visual scoring of skin pigmentation and erythema\n* To assess efficacy by skin untargeted full proteomic analysis\n* To assess efficacy by skin metabolomic analysis\n\nSafety: to follow the Adverse Events all along the study",[89],"Skin Ageing",[91,92,93,94],"Skin mitochondria","UVA1 exposure","TEM analyses","TOMM20 analyses","NOT_YET_RECRUITING","2026-09-28",{"date":98,"type":99},"2026-10-01","ACTUAL",{"date":96,"type":83},{"date":102,"type":83},"2027-04",{"name":5,"class":6}]