Completed

NCT Number: NCT03842566

Evaluation of Age-Related Skin Changes

This trial is a knowledge study utilizing skin measurement probes that are non-invasive instruments, with negligible risks for the subjects. No product will be studied.

Completed

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Key information

Conditions

Age-related Skin Changes

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Dermscan-Pharmascan

Villeurbanne, 69100, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Caucasian subjects with Fitzpatrick skin type II or III.
Subject agreeing to complete all study required procedures.
Subject having given freely and expressly 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.
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, liposuction of the thigh, or other ablative procedures) in the face or thigh 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 thigh, 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 or thigh 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, or anti-wrinkle products on the face), within 30 days prior to enrollment or is planning to begin using such products during the study.

Treatment and study plan

Primary outcomes

Age-related changes in fine lines on the cheek

Time frame: 4 Months

Measured using a 5 point photonumeric scale (Allergan Fine Lines scale)

The scale range is 0 to 4, with 0 indicating no fine lines and 4 being the most severe fine lines (greater than 5 superficial lines with crosshatching).
Age-related changes in skin hydration on the cheek

Time frame: 4 Months

Tissue dielectric constant measurement using MoistureMeter D (Delfin Technologies). Tissue dielectric constant is expressed as a unitless value that is directly proportional to the amount of water in the tissue.
Age-related changes in skin hydration on the cheek

Time frame: 4 Months

Tissue dielectric constant measurement using a Corneometer (Courage & Khazaka). Tissue dielectric constant is expressed as a unitless value that is directly proportional to the amount of water in the tissue.
Age-related changes in skin barrier function on the cheek

Time frame: 4 Months

Transepidermal water loss measurement using an AquaFlux AF100 (Biox Systems Ltd)
Age-related changes in skin radiance on the cheek

Time frame: 4 Months

Measurement of light reflection using a Skin-Glossymeter GL200 (Courage & Khazaka)
Age-related changes in skin color on the cheek

Time frame: 4 Months

Skin colorimetric measurement using a Spectrophotometer (Konica Minolta)
Age-related changes in skin melanin on the cheek

Time frame: 4 Months

Colorimetric measurement of skin melanin using a Mexameter MX18 (Courage & Khazaka)
Age-related changes in skin elasticity on the cheek and thigh

Time frame: 4 Months

Skin elasticity measurement using a Cutometer (Courage & Khazaka), ElastiMeter (Delfin Technologies), and Dermal Torque Meter (Dia-Stron Limited)
Age-related changes in skin thickness on the cheek and thigh

Time frame: 4 Months

Ultrasound imaging using a Dermascan Ultrasound (Cortex Technology)
Age-related changes in skin topography on the cheek and thigh

Time frame: 4 Months

Skin topography imaged using a PRIMOS (Canfield Scientific) fringe projection imaging system. Output measurements from the images will include Ra (average roughness), Rz (average height of roughness), and Rt (maximum height of the roughness profile).
Age-related changes in skin topography on the cheek and thigh

Time frame: 4 Months

Skin topography imaged using a DermaTOP (EOTECH) fringe projection imaging system. Output measurements from the images will include Ra (average roughness), Rz (average height of roughness), and Rt (maximum height of the roughness profile).
Age-related changes in skin density on the cheek and thigh

Time frame: 4 Months

Ultrasound imaging using a Dermascan Ultrasound (Cortex Technology)

Secondary outcomes

Reproducibility and repeatability of the skin hydration measurement on the cheek

Time frame: 4 Months

The reproducibility and repeatability of the tissue dielectric constant measurement using MoistureMeter D (Delfin Technologies) will be determined by repeating the measurement three times by two technicians
Reproducibility and repeatability of the skin hydration measurement on the cheek

Time frame: 4 Months

The reproducibility and repeatability of the tissue dielectric constant measurement using a Corneometer (Courage & Khazaka) will be determined by repeating the measurement three times by two technicians
Reproducibility and repeatability of the skin barrier function measurement on the cheek

Time frame: 4 Months

The reproducibility and repeatability of the Transepidermal water loss measurement using an AquaFlux AF100 (Biox Systems Ltd) will be determined by repeating the measurement three times by two technicians
Reproducibility and repeatability of the skin radiance measurement on the cheek

Time frame: 4 Months

The reproducibility and repeatability of the light reflection using a Skin-Glossymeter GL200 (Courage & Khazaka) will be determined by repeating the measurement three times by two technicians
Reproducibility and repeatability of the skin color measurement on the cheek

Time frame: 4 Months

The reproducibility and repeatability of the skin colorimetric measurement using a Spectrophotometer (Konica Minolta) will be determined by repeating the measurement three times by two technicians
Reproducibility and repeatability of the skin melanin changes on the cheek

Time frame: 4 Months

The reproducibility and repeatability of the colorimetric measurement of skin melanin using a Mexameter MX18 (Courage & Khazaka) will be determined by repeating the measurement three times by two technicians
Reproducibility and repeatability of the changes in skin elasticity on the cheek and thigh

Time frame: 4 Months

The reproducibility and repeatability of the skin elasticity measurement using a Cutometer (Courage & Khazaka), ElastiMeter (Delfin Technologies), and Dermal Torque Meter (Dia-Stron Limited) will be determined by repeating the measurement three times by two technicians
Reproducibility and repeatability of the changes in skin thickness and density on the cheek and thigh

Time frame: 4 Months

The reproducibility and repeatability of the measurement of ultrasound imaging using a Dermascan Ultrasound (Cortex Technology) will be determined by repeating the measurement three times by two technicians
Reproducibility and repeatability of the changes in skin topography on the cheek

Time frame: 4 Months

The reproducibility and repeatability of the skin topographyusing a PRIMOS (Canfield Scientific) fringe projection imaging system will be determined by repeating the measurement three times by two technicians
Reproducibility and repeatability of the changes in skin topography on the cheek

Time frame: 4 Months

The reproducibility and repeatability of the skin topography will be imaged using a DermaTOP (EOTECH) fringe projection imaging system and will be determined by repeating the measurement three times by two technicians

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

Evaluation of Age-Related Skin Changes Using Clinical Probe Measurements and Imaging

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Feb 15, 2019
Registry last updated: Jul 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed