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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Wrinkle Appearance; Skin Quality
• Intervention / Treatment: Other: Group 1 (Biostimulation + Test product); Other: Group 2 (Biostimulation + Placebo); Other: Group 3 (Test product Alone)

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claire Deloche-Bensmain, PhD; Phone Number: 0033776112798; Email: Claire.DELOCHE-BENSMAINE@loreal.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Female trial participants aged from 30 to 70 years.
• Trial participants who are regular users of anti-aging cosmetic products.
• Trial participants presenting with:
• Wrinkle visibility score ≥3 and ≤6 on a 10-point visual scale.
• Fine lines visibility score ≥3 and ≤6 on a 10-point visual scale.
• Crow's feet wrinkle score ≥2 and ≤4 on the L'Oréal Atlas (volume 1 caucasian type).
• Skin radiance score ≥3 and ≤6 on a 10-point visual scale.
• Plumpness score ≥3 and ≤6 on a 10-point visual scale

Exclusion Criteria:

• Trial participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.
• 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.
• 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.
• 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.
• Trial participants who have undergone biostimulation procedures in the past 6 to 9 months from the day of screening
• Trial participants with a known allergy to any component of the investigational product(s), comparator product(s), or additional products used in the study.
• 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.
• Trial participants who are unable or unwilling to comply with the study requirements and instructions.
• Trial participants who are unable to provide written informed consent.
• Trial participant with clinically significant history of alcoholism or drug abuse;
• Trial participant who are employees of MSCR or Sponsor

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 (Biostimulation + Test product); application of collagen 16 serum (morning and evening); Capital Soleil Family Milk SPF 30 (morning); La Roche-Posay Hydraphase Light (evening); Biostimulation injection at Visit 2	Other: Group 1 (Biostimulation + Test product); • Facial wrinkles, assessed by clinical scoring using the L'Oréal Atlas (volume 1 caucasian type), based on changes from baseline to Week 13. Clinical evaluations, including: Crow's feet wrinkles (0-6); Nasolabial folds (0-5); Underneath eye wrinkles (0-5); Upper lip wrinkles (0-6); Wrinkles at the corner of the lips (0-6) Clinical evaluations, including: Global wrinkles (visual assessment); Fine lines (visual assessment); Skin firmness (tactile assessment); Skin elasticity (tactile assessment); Skin tone evenness (visual assessment); Skin radiance (visual assessment); Skin smoothness (visual assessment); Ptosis of the lower part of the face (visual assessment); Plumpness (visual assessment) Instrumental measurements, including: Dermis density (SIAscope); Transepidermal water loss (TEWL) (Tewameter); Skin hydration (Corneometer); VISIA CR imaging To evaluate trial participant self-perceived efficacy using questionnaires. To assess the local tolerance and safety
Placebo Comparator: Group 2 (Biostimulation + Placebo)	Other: Group 2 (Biostimulation + Placebo); • Facial wrinkles, assessed by clinical scoring using the L'Oréal Atlas (volume 1 caucasian type), based on changes from baseline to Week 13. Clinical evaluations, including: Crow's feet wrinkles (0-6); Nasolabial folds (0-5); Underneath eye wrinkles (0-5); Upper lip wrinkles (0-6); Wrinkles at the corner of the lips (0-6) Clinical evaluations, including: Global wrinkles (visual assessment); Fine lines (visual assessment); Skin firmness (tactile assessment); Skin elasticity (tactile assessment); Skin tone evenness (visual assessment); Skin radiance (visual assessment); Skin smoothness (visual assessment); Ptosis of the lower part of the face (visual assessment); Plumpness (visual assessment) Instrumental measurements, including: Dermis density (SIAscope); Transepidermal water loss (TEWL) (Tewameter); Skin hydration (Corneometer); VISIA CR imaging To evaluate trial participant self-perceived efficacy using questionnaires. To assess the local tolerance and safety
Active Comparator: Group 3 (Test product Alone)	Other: Group 3 (Test product Alone); • Facial wrinkles, assessed by clinical scoring using the L'Oréal Atlas (volume 1 caucasian type), based on changes from baseline to Week 13. Clinical evaluations, including: Crow's feet wrinkles (0-6); Nasolabial folds (0-5); Underneath eye wrink Clinical evaluations, including: Global wrinkles (visual assessment); Fine lines (visual assessment); Skin firmness (tactile assessment); Skin elasticity (tactile assessment); Skin tone evenness (visual assessment); Skin radiance (visual assessment); Skin smoothness (visual assessment); Ptosis of the lower part of the face (visual assessment); Plumpness (visual assessment) Instrumental measurements, including: Dermis density (SIAscope); Transepidermal water loss (TEWL) (Tewameter); Skin hydration (Corneometer); VISIA CR imaging To evaluate trial participant self-perceived efficacy using questionnaires. To assess the local tolerance and safety of the investigational and comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Facial wrinkle score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=none to 9=very visible wrinkle	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	at baseline, week 3, week 7 and week 13

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global wrinkles score on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=none to 9=very visible wrinkle	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	at baseline, week 3, week 7 and week 13
Fine lines score on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=none to 9=very visible fine lines	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	at baseline, week 3, week 7 and week 13
Skin firmness score on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=very firm skin to 9=very saggy/not firm skin	skin firmness will be assessed (tactile) on a scale from 0=very firm skin to 9= very saggy/not firm skin	at baseline, week 3, week 7 and week 13
Skin elasticity on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=very elastic to 9=very loos/not elastic skin	skin elasticity will be assessed (tactil) by the investigator on a scale from 0=very elastic scale to 9=very loos/not elastic skin	at baseline, week 3, week 7 and week 13
Skin tone evenness on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=very even skin tone to 9=uneven skin tone	skin tone eveness will be visually assessed by the investigator on scale from 0=very even skin tone to 9= uneven skin tone	at baseline, week 3, week 7 and week 13
Skin radiance on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=very radiant complexion to 9=very uneven complexion/dull complexion	skin radiance will be visually assessed by the investigator on a scale from 0=very radiant complexion to 9=very uneven complexion/dull complexion	at baseline, week 3, week 7 and week 13
Skin smoothness on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=very smooth skin texture to 9=very rough skin texture	skin smoothness will be visually assessed by the investigator on a scale from 0= very smooth skin texture to 9=very rough skin texture	at baseline, week 3, week 7 and week 13
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	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)	at baseline, week 3, week 7 and week 13
Plumpness on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=very plumped skin to 9=not plumped skin	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	at baseline, week 3, week 7 and week 13
Dermis density using SIAscope (Spectophotometric intracutaneous analysis; arbitrary units)	Dermis density will be measured using SIAscope (randomized to left or right temple)	at baseline, week 3, week 7 and week 13
Transepidermal waterloss using a tewameter (g/m2/h)	transepidermal water loss will be measured using a tewameter	at baseline, week 3, week 7 and week 13
Skin hydration using a corneometer (arbitary unit)	skin hydration will be measured using a corneometer	at baseline, week 3, week 7 and week 13
Standardised imaging of the face using Visia CR imaging (no unit)	Standardised imaging of the face will be performed using Visia CR	at baseline, week 3, week 7 and week 13
Integrative health questionnaire (23 questions) developped for this study	an integrative health questionnaire will be completed by subjects 7 days before inclusion	Day -7 (7 days before baseline)
Safety assessment including local side effects and any adverse event reported by the subject during the course of the study	Evaluation of local tolerance and any adverse event by investigator and trial participants	baseline, week 3, week 7 and week 13

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-perceived efficacy using a specifically developped 20-point questionnaire (agree, somewhat agree, neither agree/neither disagree, somewhat disagree, disagree)	self-perceived efficacy will be assessed using a patient-questionaire assessing i.e. suppleness, softnes, skin texture	at week 3, week 7 and week 13

Collaborators and Investigators

• Sponsor: Vichy Laboratoires

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: February 13, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: anti-aging; cosmetics; biostimulation; collagen 16; placebo serum
• Other Study ID Numbers: VCY25-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No