Evaluation of Age-Related Skin Changes

Age-related Skin Changes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03842566
• Other study ID #: 2019-602-000
• Status: Completed
• Start date: April 18, 2019
• Est. completion date: July 12, 2019

Study information

• Verified date: July 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 12, 2019
• Est. primary completion date: July 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Age-related Skin Changes

Locations

Country	Name	City	State
France	Dermscan-Pharmascan	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age-related changes in fine lines on the cheek	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).	4 Months
Primary	Age-related changes in skin hydration on the cheek	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.	4 Months
Primary	Age-related changes in skin hydration on the cheek	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.	4 Months
Primary	Age-related changes in skin barrier function on the cheek	Transepidermal water loss measurement using an AquaFlux AF100 (Biox Systems Ltd)	4 Months
Primary	Age-related changes in skin radiance on the cheek	Measurement of light reflection using a Skin-Glossymeter GL200 (Courage & Khazaka)	4 Months
Primary	Age-related changes in skin color on the cheek	Skin colorimetric measurement using a Spectrophotometer (Konica Minolta)	4 Months
Primary	Age-related changes in skin melanin on the cheek	Colorimetric measurement of skin melanin using a Mexameter MX18 (Courage & Khazaka)	4 Months
Primary	Age-related changes in skin elasticity on the cheek and thigh	Skin elasticity measurement using a Cutometer (Courage & Khazaka), ElastiMeter (Delfin Technologies), and Dermal Torque Meter (Dia-Stron Limited)	4 Months
Primary	Age-related changes in skin thickness on the cheek and thigh	Ultrasound imaging using a Dermascan Ultrasound (Cortex Technology)	4 Months
Primary	Age-related changes in skin topography on the cheek and thigh	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).	4 Months
Primary	Age-related changes in skin topography on the cheek and thigh	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).	4 Months
Primary	Age-related changes in skin density on the cheek and thigh	Ultrasound imaging using a Dermascan Ultrasound (Cortex Technology)	4 Months
Secondary	Reproducibility and repeatability of the skin hydration measurement on the cheek	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	4 Months
Secondary	Reproducibility and repeatability of the skin hydration measurement on the cheek	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	4 Months
Secondary	Reproducibility and repeatability of the skin barrier function measurement on the cheek	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	4 Months
Secondary	Reproducibility and repeatability of the skin radiance measurement on the cheek	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	4 Months
Secondary	Reproducibility and repeatability of the skin color measurement on the cheek	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	4 Months
Secondary	Reproducibility and repeatability of the skin melanin changes on the cheek	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	4 Months
Secondary	Reproducibility and repeatability of the changes in skin elasticity on the cheek and thigh	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	4 Months
Secondary	Reproducibility and repeatability of the changes in skin thickness and density on the cheek and thigh	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	4 Months
Secondary	Reproducibility and repeatability of the changes in skin topography on the cheek	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	4 Months
Secondary	Reproducibility and repeatability of the changes in skin topography on the cheek	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	4 Months