CompletedNCT03842566Updated Jul 17, 2019

Evaluation of Age-Related Skin Changes

An observational study in Age-related Skin Changes, sponsored by Allergan. Completed at 1 site in France. Open to female participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-17.

Sponsored by Allergan · Observational

Study type: Observational
Model: Other
Time perspective: Cross-sectional
Enrollment: 100
Ages: 18 Years to 80 Years
Sex: Female

Study 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.

Conditions studied

Age-related Skin Changes

In context

Lead sponsor

Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes
Sampling method: Non-probability sample

Study population

100 female subjects will be included, with at least 10 subjects per age decade

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

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.

Study design

Observational model: Other
Time perspective: Cross-sectional
Enrollment: 100 participants (actual)
Patient registry: No

Groups and cohorts

20-29 Years Old
30-39 Years Old
40-49 Years Old
50-59 Years Old
60-69 Years Old
70-79 Years Old

What researchers measure

Primary outcomes

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).
Time frame: 4 Months
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.
Time frame: 4 Months
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.
Time frame: 4 Months
Age-related changes in skin barrier function on the cheek
Transepidermal water loss measurement using an AquaFlux AF100 (Biox Systems Ltd)
Time frame: 4 Months
Age-related changes in skin radiance on the cheek
Measurement of light reflection using a Skin-Glossymeter GL200 (Courage \& Khazaka)
Time frame: 4 Months
Age-related changes in skin color on the cheek
Skin colorimetric measurement using a Spectrophotometer (Konica Minolta)
Time frame: 4 Months
Age-related changes in skin melanin on the cheek
Colorimetric measurement of skin melanin using a Mexameter MX18 (Courage \& Khazaka)
Time frame: 4 Months
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)
Time frame: 4 Months
Age-related changes in skin thickness on the cheek and thigh
Ultrasound imaging using a Dermascan Ultrasound (Cortex Technology)
Time frame: 4 Months
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).
Time frame: 4 Months
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).
Time frame: 4 Months
Age-related changes in skin density on the cheek and thigh
Ultrasound imaging using a Dermascan Ultrasound (Cortex Technology)
Time frame: 4 Months

Secondary outcomes

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
Time frame: 4 Months
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
Time frame: 4 Months
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
Time frame: 4 Months
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
Time frame: 4 Months
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
Time frame: 4 Months
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
Time frame: 4 Months
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
Time frame: 4 Months
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
Time frame: 4 Months
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
Time frame: 4 Months
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
Time frame: 4 Months

Study locations

1 site

Dermscan-Pharmascan
Villeurbanne, 69100, France

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03842566
Lead sponsor: Allergan
Responsible party: Sponsor
First posted: Feb 15, 2019
Start date: Apr 18, 2019
Primary completion: Jul 12, 2019
Completion: Jul 12, 2019
Last update: Jul 17, 2019

Study contacts

Siham Rharbaoui, MD

principal investigator · DERMSCAN - Pharmascan

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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