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NCT Number: 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

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.

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Key information

Conditions

Wrinkle Appearance Skin Quality

Age range

30 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. 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

    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

Secondary outcomes

  1. 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

    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

  2. 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

    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

  3. 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 firmness will be assessed (tactile) on a scale from 0=very firm skin to 9= very saggy/not firm skin

  4. 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 elasticity will be assessed (tactil) by the investigator on a scale from 0=very elastic scale to 9=very loos/not elastic skin

  5. 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 tone eveness will be visually assessed by the investigator on scale from 0=very even skin tone to 9= uneven skin tone

  6. 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 radiance will be visually assessed by the investigator on a scale from 0=very radiant complexion to 9=very uneven complexion/dull complexion

  7. 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

    skin smoothness will be visually assessed by the investigator on a scale from 0= very smooth skin texture to 9=very rough skin texture

  8. 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

    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)

  9. 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

    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

  10. Dermis density using SIAscope (Spectophotometric intracutaneous analysis; arbitrary units)

    Time frame: at baseline, week 3, week 7 and week 13

    Dermis density will be measured using SIAscope (randomized to left or right temple)

  11. Transepidermal waterloss using a tewameter (g/m2/h)

    Time frame: at baseline, week 3, week 7 and week 13

    transepidermal water loss will be measured using a tewameter

  12. Skin hydration using a corneometer (arbitary unit)

    Time frame: at baseline, week 3, week 7 and week 13

    skin hydration will be measured using a corneometer

  13. Standardised imaging of the face using Visia CR imaging (no unit)

    Time frame: at baseline, week 3, week 7 and week 13

    Standardised imaging of the face will be performed using Visia CR

  14. Integrative health questionnaire (23 questions) developped for this study

    Time frame: Day -7 (7 days before baseline)

    an integrative health questionnaire will be completed by subjects 7 days before inclusion

  15. Safety assessment including local side effects and any adverse event reported by the subject during the course of the study

    Time frame: baseline, week 3, week 7 and week 13

    Evaluation of local tolerance and any adverse event by investigator and trial participants

Other outcomes

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

    Time frame: at week 3, week 7 and week 13

    self-perceived efficacy will be assessed using a patient-questionaire assessing i.e. suppleness, softnes, skin texture

Study contacts

Contact information is provided by the study sponsor or research team.

Claire Deloche-Bensmain, PhD

CONTACT

[email protected]

0033776112798

Sponsors and collaborators

Lead sponsor

Vichy Laboratoires

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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