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

Allergan

Status

Completed

Conditions

Age-related Skin Changes

Study type

Observational

Funder types

Industry

Identifiers

NCT04552249

2019-604-000

Details and patient eligibility

About

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

Enrollment

200 patients

Sex

All

Ages

20 to 79 years old

Volunteers

Accepts Healthy Volunteers

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.