Skin Ageing, Skin Density, Skin Elasticity, Skin Evenness, Skin Firmness, Skin Radiance, Skin Smoothness, Visible Skin Aging Signs, Wrinkles and Folds in Lower Face
Conditions
Brief 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 .
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
Sponsors
Vichy Laboratoires
CPCAD GIE
SKINPHARMA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
products will be investigator masked
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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: * 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).
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Crow's feet score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no wrinkles to 6=very deep severe wrinkles | Baseline, Week 3, Week 7, Week 13 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Forhead wrinkle score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no wrinkles to 5=very deep/severe wrinkles | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | baseline, week 3, week 7, week 13 | 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 |
| 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. | baseline, week 3, week 7, week 13 | 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 |
| Dermis density using SIAscope (Spectophotometric intracutaneous analysis; arbitrary units) | baseline, week 3, week 7, week 13 | 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. |
| Image acquisition: LC-OCT Acquisition | baseline, week 3, week 7, week 13 | 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. |
| Image acquisition: Selfies acquisition | baseline, week 3, week 7, week 13 | 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 |
| Image acquisition: ColorFace Acquisitions | Baseline, week 3, week 7, week 13 | 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 |
| Subject Self-Assessment Questionnaire | week 3, week 7 and week 13 | 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 |
| Global Investigator satisfaction on a scale from 0= not satisfied to 5= very satisfied with the clinical outcome | week 13 | — |
Contacts
CONTACTJulie Faure
CONTACTClaire Deloche-Bensmaine, phD
Outcome results
None listed