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Not yet recruiting 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

No phase Interventional Wrinkle Appearance Skin Quality

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Group 1 (Biostimulation + Test product), Group 2 (Biostimulation + Placebo), Group 3 (Test product Alone).
Who it may be relevant to
Registry conditions: Wrinkle Appearance, Skin Quality. Basic parameters: 30 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • 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 (tacti
  • 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 (tacti
  • 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

Primary outcome measures

  • Facial wrinkle score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=none to 9=very visible wrinkle [Time frame: at baseline, week 3, week 7 and week 13]
Secondary outcome measures (12)
  • Global wrinkles score on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=none to 9=very visible wrinkle [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: at baseline, week 3, week 7 and week 13]
  • Dermis density using SIAscope (Spectophotometric intracutaneous analysis; arbitrary units) [Time frame: at baseline, week 3, week 7 and week 13]
  • Transepidermal waterloss using a tewameter (g/m2/h) [Time frame: at baseline, week 3, week 7 and week 13]
  • Skin hydration using a corneometer (arbitary unit) [Time frame: at baseline, week 3, week 7 and week 13]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07446361 · VCY25-010

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗