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

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

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

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.

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.

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

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

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

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.