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

Age-related Skin Changes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04552249
• Other study ID #: 2019-604-000
• Status: Completed
• Start date: September 22, 2020
• Est. completion date: December 18, 2020

Study information

• Verified date: March 2021
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 18, 2020
• Est. primary completion date: December 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Age-related Skin Changes

Locations

Country	Name	City	State
France	Dermscan-Pharmascan	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Age-related changes in skin elasticity on the cheek	Skin elasticity measurement using suction based device	2 Months
Primary	Age-related changes in skin color on the cheek	Skin colorimetric measurement will be done with a Spectrophotometer	2 Months
Primary	Age-related changes in skin thickness on the cheek	Epidermal thickness will be measured with an optical coherence tomography instrument	2 Months
Primary	Age-related changes in skin blood flow on the cheek	Blood Flow (redness) will be measured with an optical coherence tomography instrument	2 Months
Primary	Age-related changes in skin roughness on the cheek	Skin surface roughness will be measured with an optical coherence tomography instrument	2 Months
Primary	Age-related changes in skin OAC on the cheek	Optical Attenuation Coefficient (OAC) will be measured with an optical coherence tomography instrument	2 Months
Primary	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
Primary	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
Primary	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
Primary	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	To evaluate the reliability of skin hydration measurement on the cheek between different time points and different technicians.		2 Months
Secondary	To evaluate the reliability of different skin elasticity measurement on the cheek between different time points and different technicians.		2 Months
Secondary	To evaluate the reliability of spectrophotometric skin color measurement on the cheek between different time points and different technicians.		2 Months
Secondary	To evaluate the reliability of epidermal thickness measurement on the cheek between different time points and different technicians.		2 Months
Secondary	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
Secondary	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
Secondary	To evaluate the reliability of skin gloss measurement on the cheek between different technicians.		2 Months

External 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