Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:24 AM
Study NCT ID:
NCT07446361
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Masking Description'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized, controlled, parallel-group design with independent assessor blinding'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-02', 'studyFirstSubmitDate': '2026-02-13', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Self-perceived efficacy using a specifically developped 20-point questionnaire (agree, somewhat agree, neither agree/neither disagree, somewhat disagree, disagree)', 'timeFrame': 'at week 3, week 7 and week 13', 'description': 'self-perceived efficacy will be assessed using a patient-questionaire assessing i.e. suppleness, softnes, skin texture'}], 'primaryOutcomes': [{'measure': "Facial wrinkle score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=none to 9=very visible wrinkle", 'timeFrame': 'at baseline, week 3, week 7 and week 13', 'description': 'wrinkles will be visually assessed on the whole face by the investigator on a scale from 0= no visible wrinkle to 9=very visible wrinkle'}], 'secondaryOutcomes': [{'measure': "Global wrinkles score on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=none to 9=very visible wrinkle", 'timeFrame': 'at baseline, week 3, week 7 and week 13', 'description': 'global wrinkles will be visually assessed on the whole face by the investigator on a scale from 0= no visible wrinkle to 9=very visible wrinkle'}, {'measure': "Fine lines score on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=none to 9=very visible fine lines", 'timeFrame': 'at baseline, week 3, week 7 and week 13', 'description': 'fine lines will be visually assessed on yhe whole face by the investigator on a scale from 0= no visible fine lines to 9=very visible fine lines'}, {'measure': "Skin firmness score on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=very firm skin to 9=very saggy/not firm skin", 'timeFrame': 'at baseline, week 3, week 7 and week 13', 'description': 'skin firmness will be assessed (tactile) on a scale from 0=very firm skin to 9= very saggy/not firm skin'}, {'measure': "Skin elasticity on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=very elastic to 9=very loos/not elastic skin", 'timeFrame': 'at baseline, week 3, week 7 and week 13', 'description': 'skin elasticity will be assessed (tactil) by the investigator on a scale from 0=very elastic scale to 9=very loos/not elastic skin'}, {'measure': "Skin tone evenness on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=very even skin tone to 9=uneven skin tone", 'timeFrame': 'at baseline, week 3, week 7 and week 13', 'description': 'skin tone eveness will be visually assessed by the investigator on scale from 0=very even skin tone to 9= uneven skin tone'}, {'measure': "Skin radiance on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=very radiant complexion to 9=very uneven complexion/dull complexion", 'timeFrame': 'at baseline, week 3, week 7 and week 13', 'description': 'skin radiance will be visually assessed by the investigator on a scale from 0=very radiant complexion to 9=very uneven complexion/dull complexion'}, {'measure': "Skin smoothness on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=very smooth skin texture to 9=very rough skin texture", 'timeFrame': 'at baseline, week 3, week 7 and week 13', 'description': 'skin smoothness will be visually assessed by the investigator on a scale from 0= very smooth skin texture to 9=very rough skin texture'}, {'measure': "Ptosis of the lower part of the face on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=no sagging skin to 9=very sagging skin", 'timeFrame': 'at baseline, week 3, week 7 and week 13', 'description': 'ptosis (skin sagginess) on the lower face will be visually assessed by the investigator on a scale from 0= no sagging skin (defined contours) to 9=very sagging skin (not defined contours)'}, {'measure': "Plumpness on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=very plumped skin to 9=not plumped skin", 'timeFrame': 'at baseline, week 3, week 7 and week 13', 'description': 'plumpness will be visually assessed by the investigator on the entire face on a scale from 0= very plumped skin to 9=not plumped skin'}, {'measure': 'Dermis density using SIAscope (Spectophotometric intracutaneous analysis; arbitrary units)', 'timeFrame': 'at baseline, week 3, week 7 and week 13', 'description': 'Dermis density will be measured using SIAscope (randomized to left or right temple)'}, {'measure': 'Transepidermal waterloss using a tewameter (g/m2/h)', 'timeFrame': 'at baseline, week 3, week 7 and week 13', 'description': 'transepidermal water loss will be measured using a tewameter'}, {'measure': 'Skin hydration using a corneometer (arbitary unit)', 'timeFrame': 'at baseline, week 3, week 7 and week 13', 'description': 'skin hydration will be measured using a corneometer'}, {'measure': 'Standardised imaging of the face using Visia CR imaging (no unit)', 'timeFrame': 'at baseline, week 3, week 7 and week 13', 'description': 'Standardised imaging of the face will be performed using Visia CR'}, {'measure': 'Integrative health questionnaire (23 questions) developped for this study', 'timeFrame': 'Day -7 (7 days before baseline)', 'description': 'an integrative health questionnaire will be completed by subjects 7 days before inclusion'}, {'measure': 'Safety assessment including local side effects and any adverse event reported by the subject during the course of the study', 'timeFrame': 'baseline, week 3, week 7 and week 13', 'description': 'Evaluation of local tolerance and any adverse event by investigator and trial participants'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anti-aging', 'cosmetics', 'collagen 16', 'biostimulation', 'placebo serum'], 'conditions': ['Wrinkle Appearance', 'Skin Quality']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "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"}, 'identificationModule': {'nctId': 'NCT07446361', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vichy Laboratoires'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'VCY25-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 (Biostimulation + Test product)', 'description': '* 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', 'interventionNames': ['Other: Group 1 (Biostimulation + Test product)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 2 (Biostimulation + Placebo)', 'interventionNames': ['Other: Group 2 (Biostimulation + Placebo)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3 (Test product Alone)', 'interventionNames': ['Other: Group 3 (Test product Alone)']}], 'interventions': [{'name': 'Group 1 (Biostimulation + Test product)', 'type': 'OTHER', 'description': "• 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", 'armGroupLabels': ['Group 1 (Biostimulation + Test product)']}, {'name': 'Group 2 (Biostimulation + Placebo)', 'type': 'OTHER', 'description': "• 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", 'armGroupLabels': ['Group 2 (Biostimulation + Placebo)']}, {'name': 'Group 3 (Test product Alone)', 'type': 'OTHER', 'description': "• 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", 'armGroupLabels': ['Group 3 (Test product Alone)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Claire Deloche-Bensmain, PhD', 'role': 'CONTACT', 'email': 'Claire.DELOCHE-BENSMAINE@loreal.com', 'phone': '0033776112798'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vichy Laboratoires', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}