Clinical trial NCT04552249: Evaluation of Age-related Skin Changes and Instrument Reliability Using Clinical Probe Measurements and Imaging Modalities
Official title: Evaluation of Age-related Skin Changes and Instrument Reliability Using Clinical Probe Measurements and Imaging Modalities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-related Skin Changes
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2020-09-17
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 subjects will be included, with at least 25 subjects per group

Brief summary: To evaluate the reliability of different non-invasive skin probe measurements.


Eligibility criteria: 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.

Primary outcomes:
measure: Age-related changes in skin hydration on the cheek
timeFrame: 2 Months
measure: Age-related changes in skin elasticity on the cheek
timeFrame: 2 Months
measure: Age-related changes in skin color on the cheek
timeFrame: 2 Months
measure: Age-related changes in skin thickness on the cheek
timeFrame: 2 Months
measure: Age-related changes in skin blood flow on the cheek
timeFrame: 2 Months
measure: Age-related changes in skin roughness on the cheek
timeFrame: 2 Months
measure: Age-related changes in skin OAC on the cheek
timeFrame: 2 Months
measure: Age-related changes in skin topography on the cheek
timeFrame: 2 Months
measure: Age-related changes in skin gloss on the cheek
timeFrame: 2 Months
measure: Age-related changes in fine lines on the cheek
timeFrame: 2 Months
measure: Clinical scoring of age-related changes in skin roughness on the cheek
timeFrame: 2 Months
Secondary outcomes:
measure: To evaluate the reliability of skin hydration measurement on the cheek between different time points and different technicians.
timeFrame: 2 Months
measure: To evaluate the reliability of different skin elasticity measurement on the cheek between different time points and different technicians.
timeFrame: 2 Months
measure: To evaluate the reliability of spectrophotometric skin color measurement on the cheek between different time points and different technicians.
timeFrame: 2 Months
measure: To evaluate the reliability of epidermal thickness measurement on the cheek between different time points and different technicians.
timeFrame: 2 Months
measure: 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.
timeFrame: 2 Months
measure: 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.
timeFrame: 2 Months
measure: To evaluate the reliability of skin gloss measurement on the cheek between different technicians.
timeFrame: 2 Months
Other outcomes:
Locations:
city: Villeurbanne
country: France
facility: Dermscan-Pharmascan
Study officials:
affiliation: DERMSCAN - Pharmascan
name: Siham Rharbaoui, MD
role: PRINCIPAL_INVESTIGATOR
References: