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| Name | Class |
|---|---|
| CPCAD GIE | UNKNOWN |
| SKINPHARMA | UNKNOWN |
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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Combined oral collagen supplement + topical collagen serum | Experimental | combination of oral collagen supplementation and topical application of collagen serum |
|
| Group 2: Oral collagen supplement alone | Active Comparator | oral collagen supplementation |
|
| Group 3: Topical collagen serum alone | Active Comparator | topical application of collagen serum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral collagen | Dietary Supplement | combination of oral collagen supplementation and topical application of collagen serum |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
A woman is considered of childbearing potential unless she is:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie Faure | Contact | +33776112798 | julie.faure@loreal.com | |
| Claire Deloche-Bensmaine, phD | Contact | +33776112798 | claire.deloche-bensmain@loreal.com |
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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:
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products will be investigator masked
| topical application of collagen serum | Other | topical application of collagen serum |
|
| 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) | 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:
| 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 | 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. | 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:
| 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 | 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:
| 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 | 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 | week 13 |
| baseline, week 13 |
| ID | Term |
|---|---|
| D003094 | Collagen |
| ID | Term |
|---|---|
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D016326 | Extracellular Matrix Proteins |
| D012596 | Scleroproteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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