ClinicalTrials.gg
Not yet recruitingNCT07473037Updated Mar 16, 2026

Efficacy of a Combined Oral and Topical Collagen Regimen Compared to Topical Collagen or Oral Collagen Regimens in Women With Skin Ageing Signs

An interventional study of Oral collagen and topical application of collagen serum in Visible Skin Aging Signs, Wrinkles and Folds in Lower Face and Skin Ageing, sponsored by Vichy Laboratoires. Not yet recruiting. Open to female participants aged 45 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-03-16.

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

Phase
Not applicable
Study type
Interventional
Enrollment
165
Allocation
Randomized
Ages
45 Years to 60 Years
Sex
Female
01

Study summary

This clinical study is conducted at one study site and in 165 women with visible signs of skin aging. It compares after 13 weeks the benefit of a combined oral collagen supplement and topical collagen serum regimen compared with oral collagen alone and topical collagen serum alone in reducing in women presenting visible signs of skin ageing .

02

Conditions studied

  • Visible Skin Aging Signs
  • Wrinkles and Folds in Lower Face
  • Skin Ageing
  • Skin Elasticity
  • Skin Firmness
  • Skin Evenness
  • Skin Radiance
  • Skin Smoothness
  • Skin Density
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
45 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

  • Participant having signed an Form (ICF) before any trial related activity is carried out;
  • Female participant;
  • Participant with a Fitzpatrick skin type I to III;
  • Participant aged 45 to 60 years inclusive at the time of signing the ICF;
  • Participant with a ≥20 and \< 29 kg/m²;
  • Participant presenting:
  • Cheek firmness score ≥3 and ≤6 on the 10-point scale;
  • Crow's feet wrinkle score ≥2 and ≤4 on the L'Oréal Atlas;
  • Global facial wrinkle score ≥3 and ≤6 on the 10-point scale.
  • Female participant of must use one of the reliable methods of during the investigation and agree not to change it during the study;

A woman is considered of childbearing potential unless she is:

  • for at least 12 months prior to screening visit;
  • Without uterus and/or both ovaries;
  • Has been surgically sterile for at least 6 months prior to Screening visit.
  • Participant must agree to use only the designated products
  • Participant willing and able to comply with all study procedures, lifestyle and dietary restrictions, and complete the entire study period
  • Participant affiliated to a health social security system (according to French Law).

Exclusion criteria

Exclusion Criteria:

  • Participant who is pregnant or who is breast feeding;
  • Participant receiving hormone replacement therapy (HRT).
  • Participant who smokes more than two cigarettes per week;
  • Participant whose alcohol intake exceeds 2 drinks per week;
  • Participant with any uncontrolled diseases such as diabetes, hypertension, hyperthyroidism or hypothyroidism;
  • Presenting or having a history of eating disorder (e.g. anorexia, food allergy) or gastro-intestinal malabsorption such as celiac disease, Crohn's disease, lactose intolerance;
  • Participant with an history of sleeve or bypass;
  • Participant with skin abnormalities (e.g., scars, excessive hair, tattooing) or any dermatosis (e.g., psoriasis, eczema, acne vulgaris) on the face which could interfere with the study;
  • Participant with history of any severe disease or current condition which, in the opinion of the Investigator would put the participant at risk by participating in the study or would interfere significantly with the evaluation of study results
  • Participant with known or suspected to any ingredient(s) of the products;
  • Participants having undergone any aesthetic procedures (such as chemical peels, laser treatments, dermabrasions, injections, anti-ageing masks, hair implants, etc.) on the test areas within 6 months prior to the start of the study are excluded.
  • Participant who, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state);
  • Participant having use systemic , drugs, or retinoids (oral or topical) within 3 months prior to study enrollment;
  • Only for participants (20 in each group) who are willing to accept skin microbiopsies: The participant who has a to skin
  • Participant impossible to contact in case of emergency;
  • Participant with current participation in any other interventional clinical study, based on interview of the Participant;
  • Participant who is in an exclusion period in the National Biomedical Research Register of the French Ministry of Health at randomization;
  • Participant who has been deprived of their freedom by administrative or legal decision, or who is under care of a guardian or legal guardianship, or Participant hospitalized in a medical or social establishment for any reason.
Terms in these criteria, in plain language(11)

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.

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.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

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.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
165 participants (estimated)

Study arms

  • Experimental
    Group 1: Combined oral collagen supplement + topical collagen serum

    combination of oral collagen supplementation and topical application of collagen serum

    Dietary Supplement: Oral collagen · Other: topical application of collagen serum

  • Active comparator
    Group 2: Oral collagen supplement alone

    oral collagen supplementation

    Dietary Supplement: Oral collagen

  • Active comparator
    Group 3: Topical collagen serum alone

    topical application of collagen serum

    Other: topical application of collagen serum

Interventions

  • Dietary supplementOral collagen

    combination of oral collagen supplementation and topical application of collagen serum

  • Othertopical application of collagen serum

    topical application of collagen serum

06

What researchers measure

Primary outcomes

  1. Crow's feet score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no wrinkles to 6=very deep severe wrinkles

    Time frame: Baseline, Week 3, Week 7, Week 13

Secondary outcomes

  1. Forhead wrinkle score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no wrinkles to 5=very deep/severe wrinkles

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

  2. Glabellar's wrinkle score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no wrinkles to 5=very deep/severe wrinkles

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

  3. Underneath eye wrinkle score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no wrinkles to 5=very deep/severe wrinkles

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

  4. Nasolabial fold score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no fold to 5=very deep/severe fold

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

  5. Upper lip wrinkle score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no wrinkles to 6=very deep/severe wrinkles

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

  6. Wrinkles of the corner of the lip score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no wrinkles to 6=very deep/severe wrinkles

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

  7. Ptosis of the lower part of the face on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no wrinkles to 5=very deep/severe fold

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

  8. Whole face wrinkles on a scale from 0=no visible wrinkle to 9= very visible wrinkle (clinical visual evaluation by the investigator)

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

  9. Skin firmness on a scale from 0=very firm skin to 9= very saggy/not firm skin (clinical tactile evaluation by the investigator)

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

  10. Skin elasticity on a scale from 0=very elastic skin to 9= very loose/not elastic skin (clinical tactile evaluation by the investigator)

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

  11. Skin tone eveness on a scale from 0=very even skin tone to 9= very even skin tone (clinical visual evaluation by the investigator)

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

  12. Skin radiance on a scale from 0=very radiant complexion to 9= uneven complexion/ dull complexion (clinical visual evaluation by the investigator)

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

  13. Skin smoothness on a scale from 0=very smooth skin texture, 9=very rough skin texture (clinical visual evaluation by the investigator)

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

  14. Skin density on a scale from0 = very low density, 9 = very high density (clinical tactile evaluation by the investigator)

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

  15. Assessment of the mechanical properties of the skin by measuring its elasticity, firmness, and viscoelasticity using a cutometer (units: penetration depth in mm/time)

    Cutometry is a widely used, non-invasive technique designed to assess the mechanical properties of the skin by measuring its elasticity, firmness, and viscoelasticity. The procedure involves applying a controlled suction force to the skin surface using a specialized probe, which lifts the skin into the device's aperture. The extent and rate at which the skin deforms under suction and then returns to its original state are recorded, providing quantitative data on skin biomechanics. Measurements will be taken on the randomized temple. In this study, the following key parameters will be selected for analysis: * R0: Total skin deformation, representing skin firmness (lower values indicate firmer skin). * R2: Gross elasticity, the ratio of elastic recovery to total deformation (reflects overall skin elasticity). * R5: Net elasticity, indicating the pure elastic portion of skin deformation, excluding viscous effects. * R7: Biological elasticity, measuring the ability of the skin to return

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

  16. Creating an imprint of a specific shape on the skin using a Dermotrac®. Its handle houses a spring-loaded piston that applies a consistent pressure of up to 2 kg on the skin.

    The Dermotrace® device (L'Oréal) is a small tool designed to create an imprint of a specific shape on the skin. Its handle houses a spring-loaded piston that applies a consistent pressure of up to 2 kg on the skin. The measuring head's marks are aligned along the axis of the thigh. During the procedure, a pressure of 1 kg is applied for 30 seconds. After this time, the head is removed, and the resulting imprint is evaluated using a reference scale provided by L'Oréal, ranging from 0 (no imprint) to 10 (a deep, clearly defined mark that accurately reflects the contours of the measuring head, including the outer circular border). The Dermotrace® score reflects the degree of skin deformation, which correlates with the mobility of fluids within the skin. The measurement should be taken on the face

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

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

    The SIAscope is a non-invasive imaging device used to assess skin pigmentation and sub-surface skin features by analyzing the absorption and scattering of light in the skin. It employs multispectral imaging technology, capturing images at different wavelengths to provide detailed information about melanin concentration, hemoglobin levels, and collagen structure beneath the skin surface. This allows for an objective evaluation of skin pigmentation disorders, sun damage, vascular conditions, and early signs of photoaging. Measurements will be taken on the randomized temple.

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

  18. Image acquisition: LC-OCT Acquisition

    Line-field Confocal Optical Coherence Tomography (LC-OCT) is a non-invasive 3D imaging technology that allows in vivo visualization of skin layers in their native state without preparation. The device enables switching between vertical (histology-like) and horizontal (confocal-like) modes and acquires volumetric 3D tissue stacks. This technique clearly images the stratum corneum, viable epidermis, dermis, and dermal-epidermal junction using live vertical, horizontal, and 3D modes. In this study, LC-OCT imaging will be performed on the forehead using the LC-OCT deepLive™ (DAMAE). The following parameters will be measured: * Stratum corneum thickness * Viable epidermis thickness * Dermal-epidermal junction undulation Three 3D stacks will be acquired per session to ensure reliable data.

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

  19. Image acquisition: Selfies acquisition

    Photographs (using both the back and front cameras) will be captured with an iPhone 15. Images taken with the back camera will be acquired by trained study personnel, while front camera images will be taken by the subjects themselves following brief instruction provided by the study staff. These photographs will be pseudonymized and stored securely in the sponsor's study files, ensuring that no personally identifiable information is included. 13.3.3.3 ColorFace Acquisitions

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

  20. Image acquisition: ColorFace Acquisitions

    Standardized photographs of the face (front and 45° left and right sides) will be taken using the ColorFace® (Newtone Technologies, Lyon, France). The ColorFace® has multiple lighting modes and can acquire up to 5 images in one setting from a user-definable shooting template without technician intervention. In this study, participants will be photographed using the following modalities: * Cross-polarized (polarizing filter angle: 90 degrees, no specular gloss on the skin surface and observation of color variations); * Standard 60 (polarizing filter angle: 60 degrees, observation of skin relief such as wrinkles); * Parallel-Polarized (polarizing filter angle: 0 degrees, observation of skin relief such as pores); All digital photographs will be named with the protocol number, the participant's SIN, the side of the body photographed, and the type of lighting used. These photographs will be pseudonymized and stored securely in the sponsor's study files, ensuring that no personally identi

    Time frame: Baseline, week 3, week 7, week 13

  21. Subject Self-Assessment Questionnaire

    At the Week 3, Week 7 and Week 13, the subjects will be questioned about the cosmetic acceptability of the study product using a 5-point scale (strongly agree, somewhat agree, neither agree nor disagree, somewhat disagree, strongly disagre) using a 20-questions questionnaire

    Time frame: week 3, week 7 and week 13

  22. Global Investigator satisfaction on a scale from 0= not satisfied to 5= very satisfied with the clinical outcome

    Time frame: week 13

Other outcomes

  1. Microbiopsies (0.33 mm in diameter or the equivalent of a 23-gauge needle) for histology and gene expression of tissue rejuvenation at baseline and week 13

    according to Kislevitz M,, Lu KB, , Wamsley C, , Hoopman J, , Kenkel J et Akgul Y, Novel Use of Non-Invasive Devices and Microbiopsies to Assess Facial Skin Rejuvenation Following Laser Treatment. . Lasers Surg Med. 2020 Nov;52(9):822-830. doi: 10.1002/lsm.23233. Epub 2020 Mar.

    Time frame: baseline, 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 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07473037
Lead sponsor
Vichy Laboratoires
Collaborators
CPCAD GIE, SKINPHARMA
Responsible party
Sponsor
First posted
Mar 16, 2026
Start date
Mar 15, 2026 (estimated)
Primary completion
Aug 15, 2026 (estimated)
Completion
Oct 31, 2026 (estimated)
Last update
Mar 16, 2026

Study contacts

Julie Faure
Contact
julie.faure@loreal.com
+33776112798
Claire Deloche-Bensmaine, phD
Contact
claire.deloche-bensmain@loreal.com
+33776112798

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 Mar 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Collagen

Start the discussion