Evaluation of Age-related Skin Changes Using Clinical Probe Measurements and Imaging Modalities in Chinese Subjects

Evaluation of age-related skin changes using clinical probe measurements and imaging modalities in Chinese subjects.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• China
  • Guangzhou
    • Haizhu, Guangzhou, China, 510032
      • Eurofins China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Female and male Chinese subjects, between 20 and 79 years old, will be included in the study. Subjects will be divided in 6 age-categories: 20-29, 30-39, 40-49, 50-59, 60-69, 70-79 years (at least 10 subjects per decade and remainder of subjects distributed among the groups) in order to evaluate age-related skin changes.

Description

Inclusion Criteria:

• Chinese subjects
• 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?

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 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
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
Age-related changes in skin hydration on the cheeks, forehead, neck and around the mouth	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 cheeks, forehead and neck	Skin elasticity measurement using suction based device	2 Months
Age-related changes in skin color on the cheeks and forehead	Skin colorimetric measurement will be done with a Spectrophotometer	2 Months
Age-related changes in skin topography on the cheeks, forehead and around the mouth	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 gloss/shine, pores, skin color and texture on the cheek, forehead and around the mouth	Skin gloss (Shine, pores, skin color and texture ) imaged using a camera-based system which uses various lighting/capture modalities to enhance the visualization of skin features	2 Months
Clinical scoring of 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To correlate the age-related skin hydration measurements on the cheeks, forehead, neck and around the mouth to clinical scoring of fine lines and skin smoothness.	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
To correlate the age-related skin elasticity measurements on the cheeks, forehead and neck to clinical scoring of fine lines and skin smoothness.	Skin elasticity measurement using suction based device	2 Months
To correlate the age-related skin color measurements on the cheeks and forehead to clinical scoring of fine lines and skin smoothness.	Skin colorimetric measurement will be done with a Spectrophotometer	2 Months
To correlate the age-related skin thickness measurements on the cheek to clinical scoring of fine lines and skin smoothness.	Epidermal thickness will be measured with an optical coherence tomography instrument	2 Months
To correlate the age-related skin blood flow measurements on the cheek to clinical scoring of fine lines and skin smoothness.	Blood Flow (redness) will be measured with an optical coherence tomography instrument	2 Months
To correlate the age-related skin roughness measurements on the cheek to clinical scoring of fine lines and skin smoothness.	Skin surface roughness will be measured with an optical coherence tomography instrument	2 Months
To correlate the age-related skin OAC measurements on the cheek to clinical scoring of fine lines and skin smoothness.	Optical Attenuation Coefficient (OAC) will be measured with an optical coherence tomography instrument	2 Months
To correlate the age-related skin topography measurements on the cheeks, forehead and around the mouth to clinical scoring of fine lines and skin smoothness.	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
To correlate the age-related gloss/shine, pores, skin color and texture on the cheek, forehead and around the mouth to clinical scoring of fine lines and skin smoothness.	Skin gloss (Shine, pores, skin color and texture ) imaged using a camera-based system which uses various lighting/capture modalities to enhance the visualization of skin features	2 Months
To correlate the age-related fine lines on the cheek to clinical scoring of fine lines and skin smoothness.	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
To correlate the age-related skin roughness on the cheek to clinical scoring of fine lines and skin smoothness.	The investigator will assess the participant's appearance of skin roughness using a 5-point scale from (0=None to 4=Diffuse)	2 Months
Age-related changes and repeatability in the perioral area for hydration and topography.	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. 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 theroughness profile)	2 Months
Age-related changes and repeatability in the neck for hydration and elasticity.	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. Skin elasticity measurement using suction based device	2 Months
Age related changes and repeatability in the forehead for hydration, color, elasticity, topography, skin gloss, color, texture, pores.	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. Skin colorimetric measurement will be done with a Spectrophotometer. Skin elasticity measurement using suction based device. 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). Skin gloss (Shine, pores, skin color and texture ) imaged using a camera-based system which uses various lighting/capture modalities to enhance the visualization of skin features.	2 Months

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Principal Investigator: Min Liu, MD, Eurofins China

Publications and helpful links

Helpful Links

• Clinical Study Report Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2021
• Primary Completion (Actual): February 5, 2021
• Study Completion (Actual): February 5, 2021

Study Registration Dates

• First Submitted: November 30, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 7, 2020

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2019-605-000

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; 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