ClinicalTrials.gg
Not yet recruitingNCT07446361Updated Mar 3, 2026

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

An interventional study of Group 1 (Biostimulation + Test product) and Group 2 (Biostimulation + Placebo) in Wrinkle Appearance and Skin Quality, sponsored by Vichy Laboratoires. Not yet recruiting. Open to female participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-03.

Sponsored by Vichy Laboratoires · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Wrinkle Appearance
  • Skin Quality

Keywords

  • anti-aging
  • cosmetics
  • collagen 16
  • biostimulation
  • placebo serum
03

In context

Lead sponsor

Vichy Laboratoires is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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 .
  • Trial participant with history of alcoholism or drug abuse;
  • Trial participant who are employees of MSCR or Sponsor
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Group 1 (Biostimulation + Test product)

    * 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)

  • Placebo comparator
    Group 2 (Biostimulation + Placebo)

    Other: Group 2 (Biostimulation + Placebo)

  • Active comparator
    Group 3 (Test product Alone)

    Other: Group 3 (Test product Alone)

Interventions

  • OtherGroup 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 (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

  • OtherGroup 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 (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

  • OtherGroup 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 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

06

What researchers measure

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

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

Secondary outcomes

  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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

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

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07446361
Lead sponsor
Vichy Laboratoires
Responsible party
Sponsor
First posted
Mar 3, 2026
Start date
Mar 1, 2026 (estimated)
Primary completion
Aug 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Mar 3, 2026

Study contacts

Claire Deloche-Bensmain, PhD
Contact
Claire.DELOCHE-BENSMAINE@loreal.com
0033776112798

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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