Evaluation of Age-related Skin Changes and Instrument Reliability Using Clinical Probe Measurements and Imaging Modalities

Study Overview
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Brief Summary
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To evaluate the reliability of different non-invasive skin probe measurements.

Official Title
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Evaluation of Age-related Skin Changes and Instrument Reliability Using Clinical Probe Measurements and Imaging Modalities

Conditions
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Age-related Skin Changes

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fitzpatrick skin type I to VI with about 15% of phototypes V/VI. Subject agreeing to complete all study required procedures. Subject having given freely and expressly his/her informed consent. Exclusion Criteria: Pregnant or nursing woman or planning a pregnancy during the study. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship. Subject in a social or sanitary establishment. Subject participating to another research on human beings or being in an exclusion period for a previous study. Intensive exposure to sunlight or UV-rays within the previous month and foreseen during the study. Subject who underwent tissue augmentation with dermal fillers including HA, calcium hydroxylapatite, autologous fat, mesotherapy, or other cosmetic procedures (eg, face-lift, laser, photomodulation, intense pulsed light, radiofrequency, dermabrasion, chemical peel, or other ablative procedures) in the face within 12 months before study entry or was planning to undergo any such treatment during the study. Subject who underwent treatment with botulinum toxins in the face or neck within 6 months of study entry or was planning to undergo such treatment during the study. Subject who ever received semi-permanent fillers or permanent facial implants (eg, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded polytetrafluoroethylene) anywhere in the face or was planning to be implanted with any of these products at any time during the study. Subject with current cutaneous inflammatory or infectious processes (eg, acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion on the face that could interfere with measurements. Subject having changed, started or stopped any hormonal treatment or any treatment likely to have an impact on skin condition (over-the-counter or prescription, oral or topical, anti-wrinkle products on the face), within 30 days prior to enrollment or is planning to begin using such products during the study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | |
| Group 2<br> | |
| Group 3<br> | |
| Group 4<br> | |
| Group 5<br> | |
| Group 6<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age-related changes in skin hydration on the cheek | Skin hydration will be measured using tissue dielectric constant measurement. Tissue dielectric constant is expressed as a unitless value that is directly proportional to the amount of water in the tissue. | 2 Months | 
| Age-related changes in skin elasticity on the cheek | Skin elasticity measurement using suction based device | 2 Months | 
| Age-related changes in skin color on the cheek | Skin colorimetric measurement will be done with a Spectrophotometer | 2 Months | 
| Age-related changes in skin thickness on the cheek | Epidermal thickness will be measured with an optical coherence tomography instrument | 2 Months | 
| Age-related changes in skin blood flow on the cheek | Blood Flow (redness) will be measured with an optical coherence tomography instrument | 2 Months | 
| Age-related changes in skin roughness on the cheek | Skin surface roughness will be measured with an optical coherence tomography instrument | 2 Months | 
| Age-related changes in skin OAC on the cheek | Optical Attenuation Coefficient (OAC) will be measured with an optical coherence tomography instrument | 2 Months | 
| Age-related changes in skin topography on the cheek | Skin topography imaged using a using a fringe projection imaging system. Output measurements from the images will include Ra (average roughness), Rq (Root Mean Square of the profile heights), RMax (Maximum Roughness Depth), Rv (Depth of the Largest Profile Valley), Rvm (Average depth of the Profile Valleys), Rz (average height of roughness) and Rt (maximum height of the roughness profile). | 2 Months | 
| Age-related changes in skin gloss on the cheek | Skin gloss (Shine and Oiliness) imaged using a camera-based system which uses various lighting/capture modalities to enhance the visualization of skin features | 2 Months | 
| Age-related changes in fine lines on the cheek | The investigator will assess the participant's appearance of fine lines/wrinkles using a 5-point scale from (0=None to 4=Diffuse) | 2 Months | 
| Clinical scoring of age-related changes in skin roughness on the cheek | The investigator will assess the participant's appearance of skin roughness using a 5-point scale from (0=None to 4=Diffuse) | 2 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the reliability of skin hydration measurement on the cheek between different time points and different technicians. |  | 2 Months | 
| To evaluate the reliability of different skin elasticity measurement on the cheek between different time points and different technicians. |  | 2 Months | 
| To evaluate the reliability of spectrophotometric skin color measurement on the cheek between different time points and different technicians. |  | 2 Months | 
| To evaluate the reliability of epidermal thickness measurement on the cheek between different time points and different technicians. |  | 2 Months | 
| To evaluate the reliability of different skin probe measurements and imaging modalities on changes in skin roughness on the cheek between different time points and different technicians. |  | 2 Months | 
| To evaluate the reliability of different skin probe measurements and imaging modalities on changes in skin gloss on the cheek between different time points and different technicians. |  | 2 Months | 
| To evaluate the reliability of skin gloss measurement on the cheek between different technicians. |  | 2 Months |