[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627263":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":17,"centralContacts":35,"locations":17,"responsibleParty":41,"collaborators":17,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":17,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":17,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":70,"whyStopped":17,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":17},{"fullName":5,"class":6},"Vichy Laboratoires","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 (Biostimulation + Test product)","EXPERIMENTAL","* application of collagen 16 serum (morning and evening)\n* Capital Soleil Family Milk SPF 30 (morning)\n* La Roche-Posay Hydraphase Light (evening)\n* Biostimulation injection at Visit 2",[13],"Other: Group 1 (Biostimulation + Test product)",{"label":15,"type":16,"description":17,"interventionNames":18},"Group 2 (Biostimulation + Placebo)","PLACEBO_COMPARATOR",null,[19],"Other: Group 2 (Biostimulation + Placebo)",{"label":21,"type":22,"description":17,"interventionNames":23},"Group 3 (Test product Alone)","ACTIVE_COMPARATOR",[24],"Other: Group 3 (Test product Alone)",[26,30,32],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":17},"OTHER","• Facial wrinkles, assessed by clinical scoring using the L'Oréal Atlas (volume 1 caucasian type), based on changes from baseline to Week 13.\n\nClinical evaluations, including:\n\n* Crow's feet wrinkles (0-6)\n* Nasolabial folds (0-5)\n* Underneath eye wrinkles (0-5)\n* Upper lip wrinkles (0-6)\n* Wrinkles at the corner of the lips (0-6)\n\nClinical evaluations, including:\n\n* Global wrinkles (visual assessment)\n* Fine lines (visual assessment)\n* Skin firmness (tactile assessment)\n* Skin elasticity (tactile assessment)\n* Skin tone evenness (visual assessment)\n* Skin radiance (visual assessment)\n* Skin smoothness (visual assessment)\n* Ptosis of the lower part of the face (visual assessment)\n* Plumpness (visual assessment)\n\nInstrumental measurements, including:\n\n* Dermis density (SIAscope)\n* Transepidermal water loss (TEWL) (Tewameter)\n* Skin hydration (Corneometer)\n* VISIA CR imaging\n\nTo evaluate trial participant self-perceived efficacy using questionnaires.\n\nTo assess the local tolerance and safety",[9],{"type":27,"name":15,"description":28,"armGroupLabels":31,"otherNames":17},[15],{"type":27,"name":21,"description":33,"armGroupLabels":34,"otherNames":17},"• Facial wrinkles, assessed by clinical scoring using the L'Oréal Atlas (volume 1 caucasian type), based on changes from baseline to Week 13.\n\nClinical evaluations, including:\n\n* Crow's feet wrinkles (0-6)\n* Nasolabial folds (0-5)\n* Underneath eye wrink\n\nClinical evaluations, including:\n\n* Global wrinkles (visual assessment)\n* Fine lines (visual assessment)\n* Skin firmness (tactile assessment)\n* Skin elasticity (tactile assessment)\n* Skin tone evenness (visual assessment)\n* Skin radiance (visual assessment)\n* Skin smoothness (visual assessment)\n* Ptosis of the lower part of the face (visual assessment)\n* Plumpness (visual assessment)\n\nInstrumental measurements, including:\n\n* Dermis density (SIAscope)\n* Transepidermal water loss (TEWL) (Tewameter)\n* Skin hydration (Corneometer)\n* VISIA CR imaging\n\nTo evaluate trial participant self-perceived efficacy using questionnaires.\n\nTo assess the local tolerance and safety of the investigational and comparator",[21],[36],{"name":37,"role":38,"phone":39,"phoneExt":17,"email":40},"Claire Deloche-Bensmain, PhD","CONTACT","0033776112798","Claire.DELOCHE-BENSMAINE@loreal.com",{"type":42,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100627263","a-study-to-evaluate-the-efficacy-of-collagen-16-serum-alone-against-and-as-an-adjunct-to-radiesse-biostimulation-procedure-in-female-trial-participants-with-aged-skin-100627263",false,"NCT07446361","A Study to Evaluate the Efficacy of Collagen 16 Serum Alone, Against and as an Adjunct to Radiesse® Biostimulation Procedure in Female Trial Participants With Aged Skin","A Randomized Clinical Study to Evaluate the Efficacy of Collagen 16 Serum Alone, Against and as an Adjunct to Radiesse® Biostimulation Procedure in Female Trial Participants With Aged Skin","Inclusion Criteria:\n\n* Female trial participants aged from 30 to 70 years.\n* Trial participants who are regular users of anti-aging cosmetic products.\n* Trial participants presenting with:\n* Wrinkle visibility score ≥3 and ≤6 on a 10-point visual scale.\n* Fine lines visibility score ≥3 and ≤6 on a 10-point visual scale.\n* Crow's feet wrinkle score ≥2 and ≤4 on the L'Oréal Atlas (volume 1 caucasian type).\n* Skin radiance score ≥3 and ≤6 on a 10-point visual scale.\n* Plumpness score ≥3 and ≤6 on a 10-point visual scale\n\nExclusion Criteria:\n\n* Trial participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.\n* Trial participants who are currently participating in another facial clinical study or who have participated in such a study within 1 month that may interfere with the study outcomes.\n* Trial participants presenting with current flaring or severe inflammatory acne or any active dermatological condition that, in the investigator's opinion, could interfere with study assessments.\n* Trial participants who have undergone ablative laser treatments, microneedling, chemical peels, dermabrasion, non-ablative laser, intense pulsed light (IPL), or injectable procedures within the last 12 months from the day of screening.\n* Trial participants who have undergone biostimulation procedures in the past 6 to 9 months from the day of screening\n* Trial participants with a known allergy to any component of the investigational product(s), comparator product(s), or additional products used in the study.\n* Trial participants presenting with any medical or dermatological condition that, in the investigator's opinion, may compromise trial participant safety or interfere with study conduct or evaluation.\n* Trial participants who are unable or unwilling to comply with the study requirements and instructions.\n* Trial participants who are unable to provide written informed consent.\n* Trial participant with clinically significant history of alcoholism or drug abuse;\n* Trial participant who are employees of MSCR or Sponsor",true,"FEMALE","30 Years","70 Years",{"count":55,"type":56},180,"ESTIMATED","INTERVENTIONAL",[59],"NA","This study aims at assessing the efficacy of improving skin aging signs of a serum containing collagen 16 combined with a biostimulation device in healthy female subjects aged between 30 and 70 years over a period of 13 weeks.",[62,63],"Wrinkle Appearance","Skin Quality",[65,66,67,68,69],"anti-aging","cosmetics","collagen 16","biostimulation","placebo serum","NOT_YET_RECRUITING","2026-03-02",{"date":73,"type":74},"2026-03-03","ACTUAL",{"date":76,"type":56},"2026-03-01",{"date":78,"type":56},"2026-09",{"name":5,"class":6}]