Evaluation of Age-related Skin Changes and Instrument Reliability Using Clinical Probe Measurements and Imaging Modalities

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

Study Overview

• Status: Completed
• Conditions: Age-related Skin Changes

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• France
  • Villeurbanne, France, 69100
    • Dermscan-Pharmascan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

200 subjects will be included, with at least 25 subjects per group

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
Group 1
Group 2
Group 3
Group 4
Group 5
Group 6

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age-related changes in skin hydration on the cheek	Skin hydration will be measured using tissue dielectric constant measurement. Tissue dielectric constant is expressed as a unitless value that is directly proportional to the amount of water in the tissue.	2 Months
Age-related changes in skin elasticity on the cheek	Skin elasticity measurement using suction based device	2 Months
Age-related changes in skin color on the cheek	Skin colorimetric measurement will be done with a Spectrophotometer	2 Months
Age-related changes in skin thickness on the cheek	Epidermal thickness will be measured with an optical coherence tomography instrument	2 Months
Age-related changes in skin blood flow on the cheek	Blood Flow (redness) will be measured with an optical coherence tomography instrument	2 Months
Age-related changes in skin roughness on the cheek	Skin surface roughness will be measured with an optical coherence tomography instrument	2 Months
Age-related changes in skin OAC on the cheek	Optical Attenuation Coefficient (OAC) will be measured with an optical coherence tomography instrument	2 Months
Age-related changes in skin topography on the cheek	Skin topography imaged using a using a fringe projection imaging system. Output measurements from the images will include Ra (average roughness), Rq (Root Mean Square of the profile heights), RMax (Maximum Roughness Depth), Rv (Depth of the Largest Profile Valley), Rvm (Average depth of the Profile Valleys), Rz (average height of roughness) and Rt (maximum height of the roughness profile).	2 Months
Age-related changes in skin gloss on the cheek	Skin gloss (Shine and Oiliness) imaged using a camera-based system which uses various lighting/capture modalities to enhance the visualization of skin features	2 Months
Age-related changes in fine lines on the cheek	The investigator will assess the participant's appearance of fine lines/wrinkles using a 5-point scale from (0=None to 4=Diffuse)	2 Months
Clinical scoring of age-related changes in skin roughness on the cheek	The investigator will assess the participant's appearance of skin roughness using a 5-point scale from (0=None to 4=Diffuse)	2 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the reliability of skin hydration measurement on the cheek between different time points and different technicians.	2 Months
To evaluate the reliability of different skin elasticity measurement on the cheek between different time points and different technicians.	2 Months
To evaluate the reliability of spectrophotometric skin color measurement on the cheek between different time points and different technicians.	2 Months
To evaluate the reliability of epidermal thickness measurement on the cheek between different time points and different technicians.	2 Months
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.	2 Months
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.	2 Months
To evaluate the reliability of skin gloss measurement on the cheek between different technicians.	2 Months

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Principal Investigator: Siham Rharbaoui, MD, DERMSCAN - Pharmascan

Publications and helpful links

Helpful Links

• Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2020
• Primary Completion (Actual): December 18, 2020
• Study Completion (Actual): December 18, 2020

Study Registration Dates

• First Submitted: September 11, 2020
• First Submitted That Met QC Criteria: September 11, 2020
• First Posted (Actual): September 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 5, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2019-604-000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.
• IPD Sharing Time Frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
• IPD Sharing Access Criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
• IPD Sharing Supporting Information Type: Study Protocol; Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No