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

NCT07446361 | Not Yet Recruiting

• 1 other identifier: VCY25-010
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Wrinkle Appearance; Skin Quality

Keywords

anti-aging; cosmetics; collagen 16; biostimulation; placebo serum

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Global wrinkles score on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=none 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

  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

  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

  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

  at baseline, week 3, week 7 and week 13

Other Outcomes (1)

• Self-perceived efficacy using a specifically developped 20-point questionnaire (agree, somewhat agree, neither agree/neither disagree, somewhat disagree, disagree)

  at week 3, week 7 and week 13

Study Arms (3)

Group 1 (Biostimulation + Test product)

EXPERIMENTAL

* 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)

Group 2 (Biostimulation + Placebo)

PLACEBO COMPARATOR

Other: Group 2 (Biostimulation + Placebo)

Group 3 (Test product Alone)

ACTIVE COMPARATOR

Other: Group 3 (Test product Alone)

Interventions

Group 1 (Biostimulation + Test product) OTHER

• 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

Group 1 (Biostimulation + Test product)

Group 2 (Biostimulation + Placebo) OTHER

• 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

Group 2 (Biostimulation + Placebo)

Group 3 (Test product Alone) OTHER

• 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

Group 3 (Test product Alone)

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vichy Laboratoires: lead

Central Study Contacts

Claire Deloche-Bensmain, PhD

CONTACT

0033776112798; Claire.DELOCHE-BENSMAINE@loreal.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masking Description
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, controlled, parallel-group design with independent assessor blinding

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: March 3, 2026
• Study Start: March 1, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share