Clinical trial NCT04655300: Evaluation of Age-related Skin Changes Using Clinical Probe Measurements and Imaging Modalities in Chinese Subjects
Official title: Evaluation of Age-related Skin Changes Using Clinical Probe Measurements and Imaging Modalities in Chinese Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-related Skin Changes
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2020-12-07
Enrollment: 102
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: 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.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Age-related changes in skin hydration on the cheeks, forehead, neck and around the mouth
timeFrame: 2 Months
measure: Age-related changes in skin elasticity on the cheeks, forehead and neck
timeFrame: 2 Months
measure: Age-related changes in skin color on the cheeks and forehead
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 cheeks, forehead and around the mouth
timeFrame: 2 Months
measure: Age-related changes in gloss/shine, pores, skin color and texture on the cheek, forehead and around the mouth
timeFrame: 2 Months
measure: Clinical scoring of 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 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.
timeFrame: 2 Months
measure: To correlate the age-related skin elasticity measurements on the cheeks, forehead and neck to clinical scoring of fine lines and skin smoothness.
timeFrame: 2 Months
measure: To correlate the age-related skin color measurements on the cheeks and forehead to clinical scoring of fine lines and skin smoothness.
timeFrame: 2 Months
measure: To correlate the age-related skin thickness measurements on the cheek to clinical scoring of fine lines and skin smoothness.
timeFrame: 2 Months
measure: To correlate the age-related skin blood flow measurements on the cheek to clinical scoring of fine lines and skin smoothness.
timeFrame: 2 Months
measure: To correlate the age-related skin roughness measurements on the cheek to clinical scoring of fine lines and skin smoothness.
timeFrame: 2 Months
measure: To correlate the age-related skin OAC measurements on the cheek to clinical scoring of fine lines and skin smoothness.
timeFrame: 2 Months
measure: 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.
timeFrame: 2 Months
measure: 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.
timeFrame: 2 Months
measure: To correlate the age-related fine lines on the cheek to clinical scoring of fine lines and skin smoothness.
timeFrame: 2 Months
measure: To correlate the age-related skin roughness on the cheek to clinical scoring of fine lines and skin smoothness.
timeFrame: 2 Months
measure: Age-related changes and repeatability in the perioral area for hydration and topography.
timeFrame: 2 Months
measure: Age-related changes and repeatability in the neck for hydration and elasticity.
timeFrame: 2 Months
measure: Age related changes and repeatability in the forehead for hydration, color, elasticity, topography, skin gloss, color, texture, pores.
timeFrame: 2 Months
Other outcomes:
Locations:
city: Haizhu
country: China
facility: Eurofins China
state: Guangzhou
Study officials:
affiliation: Eurofins China
name: Min Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: