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 | Crick

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

180

Conditions

Wrinkle Appearance Skin Quality

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 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

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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