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Evaluation of Age-Related Skin Changes

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ClinicalTrials.gov Identifier: NCT03842566
Recruitment Status : Completed
First Posted : February 15, 2019
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
This trial is a knowledge study utilizing skin measurement probes that are non-invasive instruments, with negligible risks for the subjects. No product will be studied.

Condition or disease
Age-related Skin Changes

Study Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Evaluation of Age-Related Skin Changes Using Clinical Probe Measurements and Imaging
Actual Study Start Date : April 18, 2019
Actual Primary Completion Date : July 12, 2019
Actual Study Completion Date : July 12, 2019
Groups and Cohorts
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Group/Cohort
20-29 Years Old
30-39 Years Old
40-49 Years Old
50-59 Years Old
60-69 Years Old
70-79 Years Old


Outcome Measures
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Primary Outcome Measures :
  1. Age-related changes in fine lines on the cheek [ Time Frame: 4 Months ]

    Measured using a 5 point photonumeric scale (Allergan Fine Lines scale)

    The scale range is 0 to 4, with 0 indicating no fine lines and 4 being the most severe fine lines (greater than 5 superficial lines with crosshatching).


  2. Age-related changes in skin hydration on the cheek [ Time Frame: 4 Months ]
    Tissue dielectric constant measurement using MoistureMeter D (Delfin Technologies). Tissue dielectric constant is expressed as a unitless value that is directly proportional to the amount of water in the tissue.

  3. Age-related changes in skin hydration on the cheek [ Time Frame: 4 Months ]
    Tissue dielectric constant measurement using a Corneometer (Courage & Khazaka). Tissue dielectric constant is expressed as a unitless value that is directly proportional to the amount of water in the tissue.

  4. Age-related changes in skin barrier function on the cheek [ Time Frame: 4 Months ]
    Transepidermal water loss measurement using an AquaFlux AF100 (Biox Systems Ltd)

  5. Age-related changes in skin radiance on the cheek [ Time Frame: 4 Months ]
    Measurement of light reflection using a Skin-Glossymeter GL200 (Courage & Khazaka)

  6. Age-related changes in skin color on the cheek [ Time Frame: 4 Months ]
    Skin colorimetric measurement using a Spectrophotometer (Konica Minolta)

  7. Age-related changes in skin melanin on the cheek [ Time Frame: 4 Months ]
    Colorimetric measurement of skin melanin using a Mexameter MX18 (Courage & Khazaka)

  8. Age-related changes in skin elasticity on the cheek and thigh [ Time Frame: 4 Months ]
    Skin elasticity measurement using a Cutometer (Courage & Khazaka), ElastiMeter (Delfin Technologies), and Dermal Torque Meter (Dia-Stron Limited)

  9. Age-related changes in skin thickness on the cheek and thigh [ Time Frame: 4 Months ]
    Ultrasound imaging using a Dermascan Ultrasound (Cortex Technology)

  10. Age-related changes in skin topography on the cheek and thigh [ Time Frame: 4 Months ]
    Skin topography imaged using a PRIMOS (Canfield Scientific) fringe projection imaging system. Output measurements from the images will include Ra (average roughness), Rz (average height of roughness), and Rt (maximum height of the roughness profile).

  11. Age-related changes in skin topography on the cheek and thigh [ Time Frame: 4 Months ]
    Skin topography imaged using a DermaTOP (EOTECH) fringe projection imaging system. Output measurements from the images will include Ra (average roughness), Rz (average height of roughness), and Rt (maximum height of the roughness profile).

  12. Age-related changes in skin density on the cheek and thigh [ Time Frame: 4 Months ]
    Ultrasound imaging using a Dermascan Ultrasound (Cortex Technology)


Secondary Outcome Measures :
  1. Reproducibility and repeatability of the skin hydration measurement on the cheek [ Time Frame: 4 Months ]
    The reproducibility and repeatability of the tissue dielectric constant measurement using MoistureMeter D (Delfin Technologies) will be determined by repeating the measurement three times by two technicians

  2. Reproducibility and repeatability of the skin hydration measurement on the cheek [ Time Frame: 4 Months ]
    The reproducibility and repeatability of the tissue dielectric constant measurement using a Corneometer (Courage & Khazaka) will be determined by repeating the measurement three times by two technicians

  3. Reproducibility and repeatability of the skin barrier function measurement on the cheek [ Time Frame: 4 Months ]
    The reproducibility and repeatability of the Transepidermal water loss measurement using an AquaFlux AF100 (Biox Systems Ltd) will be determined by repeating the measurement three times by two technicians

  4. Reproducibility and repeatability of the skin radiance measurement on the cheek [ Time Frame: 4 Months ]
    The reproducibility and repeatability of the light reflection using a Skin-Glossymeter GL200 (Courage & Khazaka) will be determined by repeating the measurement three times by two technicians

  5. Reproducibility and repeatability of the skin color measurement on the cheek [ Time Frame: 4 Months ]
    The reproducibility and repeatability of the skin colorimetric measurement using a Spectrophotometer (Konica Minolta) will be determined by repeating the measurement three times by two technicians

  6. Reproducibility and repeatability of the skin melanin changes on the cheek [ Time Frame: 4 Months ]
    The reproducibility and repeatability of the colorimetric measurement of skin melanin using a Mexameter MX18 (Courage & Khazaka) will be determined by repeating the measurement three times by two technicians

  7. Reproducibility and repeatability of the changes in skin elasticity on the cheek and thigh [ Time Frame: 4 Months ]
    The reproducibility and repeatability of the skin elasticity measurement using a Cutometer (Courage & Khazaka), ElastiMeter (Delfin Technologies), and Dermal Torque Meter (Dia-Stron Limited) will be determined by repeating the measurement three times by two technicians

  8. Reproducibility and repeatability of the changes in skin thickness and density on the cheek and thigh [ Time Frame: 4 Months ]
    The reproducibility and repeatability of the measurement of ultrasound imaging using a Dermascan Ultrasound (Cortex Technology) will be determined by repeating the measurement three times by two technicians

  9. Reproducibility and repeatability of the changes in skin topography on the cheek [ Time Frame: 4 Months ]
    The reproducibility and repeatability of the skin topographyusing a PRIMOS (Canfield Scientific) fringe projection imaging system will be determined by repeating the measurement three times by two technicians

  10. Reproducibility and repeatability of the changes in skin topography on the cheek [ Time Frame: 4 Months ]
    The reproducibility and repeatability of the skin topography will be imaged using a DermaTOP (EOTECH) fringe projection imaging system and will be determined by repeating the measurement three times by two technicians


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
100 female subjects will be included, with at least 10 subjects per age decade
Criteria

Inclusion Criteria:

  • Caucasian subjects with Fitzpatrick skin type II or III.
  • Subject agreeing to complete all study required procedures.
  • Subject having given freely and expressly 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.
  • 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, liposuction of the thigh, or other ablative procedures) in the face or thigh 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 thigh, 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 or thigh 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, or anti-wrinkle products on the face), within 30 days prior to enrollment or is planning to begin using such products during the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03842566


Locations
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France
Dermscan-Pharmascan
Villeurbanne, France, 69100
Sponsors and Collaborators
Allergan
Investigators
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Principal Investigator: Siham Rharbaoui, MD DERMSCAN - Pharmascan
More Information
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03842566    
Other Study ID Numbers: 2019-602-000
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No