Clinical trial NCT03842566: Evaluation of Age-Related Skin Changes
Official title: Evaluation of Age-Related Skin Changes Using Clinical Probe Measurements and Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-related Skin Changes
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2019-02-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 female subjects will be included, with at least 10 subjects per age decade

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Age-related changes in fine lines on the cheek
timeFrame: 4 Months
measure: Age-related changes in skin hydration on the cheek
timeFrame: 4 Months
measure: Age-related changes in skin hydration on the cheek
timeFrame: 4 Months
measure: Age-related changes in skin barrier function on the cheek
timeFrame: 4 Months
measure: Age-related changes in skin radiance on the cheek
timeFrame: 4 Months
measure: Age-related changes in skin color on the cheek
timeFrame: 4 Months
measure: Age-related changes in skin melanin on the cheek
timeFrame: 4 Months
measure: Age-related changes in skin elasticity on the cheek and thigh
timeFrame: 4 Months
measure: Age-related changes in skin thickness on the cheek and thigh
timeFrame: 4 Months
measure: Age-related changes in skin topography on the cheek and thigh
timeFrame: 4 Months
measure: Age-related changes in skin topography on the cheek and thigh
timeFrame: 4 Months
measure: Age-related changes in skin density on the cheek and thigh
timeFrame: 4 Months
Secondary outcomes:
measure: Reproducibility and repeatability of the skin hydration measurement on the cheek
timeFrame: 4 Months
measure: Reproducibility and repeatability of the skin hydration measurement on the cheek
timeFrame: 4 Months
measure: Reproducibility and repeatability of the skin barrier function measurement on the cheek
timeFrame: 4 Months
measure: Reproducibility and repeatability of the skin radiance measurement on the cheek
timeFrame: 4 Months
measure: Reproducibility and repeatability of the skin color measurement on the cheek
timeFrame: 4 Months
measure: Reproducibility and repeatability of the skin melanin changes on the cheek
timeFrame: 4 Months
measure: Reproducibility and repeatability of the changes in skin elasticity on the cheek and thigh
timeFrame: 4 Months
measure: Reproducibility and repeatability of the changes in skin thickness and density on the cheek and thigh
timeFrame: 4 Months
measure: Reproducibility and repeatability of the changes in skin topography on the cheek
timeFrame: 4 Months
measure: Reproducibility and repeatability of the changes in skin topography on the cheek
timeFrame: 4 Months
Other outcomes:
Locations:
city: Villeurbanne
country: France
facility: Dermscan-Pharmascan
Study officials:
affiliation: DERMSCAN - Pharmascan
name: Siham Rharbaoui, MD
role: PRINCIPAL_INVESTIGATOR
References: