Visible Skin Aging SignsNCT07473037
Efficacy of a Combined Oral and Topical Collagen Regimen Compared to Topical Collagen or Oral Collagen Regimens in Women With Skin Ageing Signs
A study testing Oral collagen and topical application of collagen serum in people with Visible Skin Aging Signs and Wrinkles and Folds in Lower Face, run by Vichy Laboratoires.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Visible Skin Aging Signs, Wrinkles and Folds in Lower Face, Skin Ageing
- What is being tested?
- Oral collagen and topical application of collagen serum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2026to 31 Oct 2026
- Phase
- Interventional
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 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Participant having signed an Informed Consent 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 BMI ≥20 and < 29 kg/m²;
- Participant presenting:
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- 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 childbearing potential must use one of the reliable methods of contraception during the investigation and agree not to change it during the study;
- A woman is considered of childbearing potential unless she is:
- Postmenopausal 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).
Who cannot join
- 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;
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- 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 hypersensitivity to any ingredient(s) of the investigational 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 corticosteroids, immunosuppressive 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 contraindication to skin biopsies
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Efficacy of an in and Out Collagen Routine Versus the Serum Alone and Versus the Oral Supplement Alone in Women With Skin Ageing Signs
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 .
- Conditions
- Visible Skin Aging Signs, Wrinkles and Folds in Lower Face, Skin Ageing, Skin Elasticity, Skin Firmness, Skin Evenness
- Being tested
- Oral collagen, topical application of collagen serum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral collagenDietary supplement
combination of oral collagen supplementation and topical application of collagen serum
topical application of collagen serumOther
topical application of collagen serum
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Combined oral collagen supplement + topical collagen serum | Experimental | combination of oral collagen supplementation and topical application of collagen serum Receives: Dietary Supplement: Oral collagen; Other: topical application of collagen serum |
| Group 2: Oral collagen supplement alone | Active comparator | oral collagen supplementation Receives: Dietary Supplement: Oral collagen |
| Group 3: Topical collagen serum alone | Active comparator | topical application of collagen serum Receives: Other: topical application of collagen serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crow's feet score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no wrinkles to 6=very deep severe wrinkles
Measured: Baseline, Week 3, Week 7, Week 13
Secondary outcomes (22)
Forhead wrinkle score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no wrinkles to 5=very deep/severe wrinkles
Measured: baseline, week 3, week 7, week 13
Glabellar's wrinkle score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no wrinkles to 5=very deep/severe wrinkles
Measured: baseline, week 3, week 7, week 13
Underneath eye wrinkle score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no wrinkles to 5=very deep/severe wrinkles
Measured: baseline, week 3, week 7, week 13
Nasolabial fold score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no fold to 5=very deep/severe fold
Measured: baseline, week 3, week 7, week 13
Upper lip wrinkle score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no wrinkles to 6=very deep/severe wrinkles
Measured: baseline, week 3, week 7, week 13
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
Measured: baseline, week 3, week 7, week 13
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
Measured: baseline, week 3, week 7, week 13
Whole face wrinkles on a scale from 0=no visible wrinkle to 9= very visible wrinkle (clinical visual evaluation by the investigator)
Measured: baseline, week 3, week 7, week 13
Skin firmness on a scale from 0=very firm skin to 9= very saggy/not firm skin (clinical tactile evaluation by the investigator)
Measured: baseline, week 3, week 7, week 13
Skin elasticity on a scale from 0=very elastic skin to 9= very loose/not elastic skin (clinical tactile evaluation by the investigator)
Measured: baseline, week 3, week 7, week 13
Skin tone eveness on a scale from 0=very even skin tone to 9= very even skin tone (clinical visual evaluation by the investigator)
Measured: baseline, week 3, week 7, week 13
Skin radiance on a scale from 0=very radiant complexion to 9= uneven complexion/ dull complexion (clinical visual evaluation by the investigator)
Measured: baseline, week 3, week 7, week 13
Skin smoothness on a scale from 0=very smooth skin texture, 9=very rough skin texture (clinical visual evaluation by the investigator)
Measured: baseline, week 3, week 7, week 13
Skin density on a scale from0 = very low density, 9 = very high density (clinical tactile evaluation by the investigator)
Measured: baseline, week 3, week 7, week 13
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
Measured: baseline, week 3, week 7, week 13
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
Measured: baseline, week 3, week 7, week 13
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.
Measured: baseline, week 3, week 7, week 13
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.
Measured: baseline, week 3, week 7, week 13
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
Measured: baseline, week 3, week 7, week 13
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
Measured: Baseline, week 3, week 7, week 13
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
Measured: week 3, week 7 and week 13
Global Investigator satisfaction on a scale from 0= not satisfied to 5= very satisfied with the clinical outcome
Measured: week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completion15 Aug 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visible Skin Aging SignsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-center, single-blind, randomized, parallel-group study involving 165 women with visible signs of skin ageing. Participants will be enrolled and randomized in equal proportions across three groups (55 participants per group) as follows: * Group 1: Combined oral collagen supplement + topical collagen serum; * Group 2: Oral collagen supplement alone; * Group 3: Topical collagen serum alone.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vichy Laboratoires
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CPCAD GIE, SKINPHARMA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473037
- Sponsor's protocol ID
- VCY25-007
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No