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Wrinkle AppearanceNCT07446361

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 study testing Group 1 (Biostimulation + Test product) and Group 3 (Test product Alone) in people with Wrinkle Appearance and Skin Quality, run by Vichy Laboratoires.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Wrinkle Appearance, Skin Quality
What is being tested?
Group 1 (Biostimulation + Test product) and Group 3 (Test product Alone)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
No sites listed yet
Study dates
1 Mar 2026to Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 11Show fewer
  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Claire Deloche-Bensmain, PhD contact

0033776112798

Claire.DELOCHE-BENSMAINE@loreal.com

About this study

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

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.

Being tested
Group 1 (Biostimulation + Test product), Group 2 (Biostimulation + Placebo), Group 3 (Test product Alone)
Keywords
anti-aging, cosmetics, collagen 16, biostimulation, placebo serum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT07446361
Study groupRoleWhat they receive
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
Receives: Other: Group 1 (Biostimulation + Test product)
Group 2 (Biostimulation + Placebo)Placebo comparatorNot described
Receives: Other: Group 2 (Biostimulation + Placebo)
Group 3 (Test product Alone)Active comparatorNot described
Receives: Other: Group 3 (Test product Alone)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: at baseline, week 3, week 7 and week 13

Secondary outcomes (15)
  1. 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

    Measured: at baseline, week 3, week 7 and week 13

  2. 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

    Measured: at baseline, week 3, week 7 and week 13

  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

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

    Measured: at baseline, week 3, week 7 and week 13

  4. 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

    Measured: at baseline, week 3, week 7 and week 13

  5. 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

    Measured: at baseline, week 3, week 7 and week 13

  6. 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

    Measured: at baseline, week 3, week 7 and week 13

  7. 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

    Measured: at baseline, week 3, week 7 and week 13

  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

    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)

    Measured: at baseline, week 3, week 7 and week 13

  9. 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

    Measured: at baseline, week 3, week 7 and week 13

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

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

    Measured: at baseline, week 3, week 7 and week 13

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

    transepidermal water loss will be measured using a tewameter

    Measured: at baseline, week 3, week 7 and week 13

  12. Skin hydration using a corneometer (arbitary unit)

    skin hydration will be measured using a corneometer

    Measured: at baseline, week 3, week 7 and week 13

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

    Standardised imaging of the face will be performed using Visia CR

    Measured: at baseline, week 3, week 7 and week 13

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

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

    Measured: Day -7 (7 days before baseline)

  15. 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

    Measured: baseline, week 3, week 7 and week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2026
  2. Study start1 Mar 2026 (estimated)
  3. Primary completionAug 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized, controlled, parallel-group design with independent assessor blinding
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07446361
Sponsor's protocol ID
VCY25-010
Status last verified
Feb 2026
First submitted
13 Feb 2026
Last updated
3 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Group 1 (Biostimulation + Test product) and Group 3 (Test product Alone) in people with Wrinkle Appearance and Skin Quality, run by Vichy Laboratoires.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Claire Deloche-Bensmain, PhD (0033776112798, Claire.DELOCHE-BENSMAINE@loreal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.

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