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

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ClinicalTrials.gov Identifier: NCT04552249
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : September 28, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date September 11, 2020
First Posted Date September 17, 2020
Last Update Posted Date September 28, 2020
Actual Study Start Date September 22, 2020
Estimated Primary Completion Date January 29, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 11, 2020)
  • Age-related changes in skin hydration on the cheek [ Time Frame: 2 Months ]
    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.
  • Age-related changes in skin elasticity on the cheek [ Time Frame: 2 Months ]
    Skin elasticity measurement using suction based device
  • Age-related changes in skin color on the cheek [ Time Frame: 2 Months ]
    Skin colorimetric measurement will be done with a Spectrophotometer
  • Age-related changes in skin thickness on the cheek [ Time Frame: 2 Months ]
    Epidermal thickness will be measured with an optical coherence tomography instrument
  • Age-related changes in skin blood flow on the cheek [ Time Frame: 2 Months ]
    Blood Flow (redness) will be measured with an optical coherence tomography instrument
  • Age-related changes in skin roughness on the cheek [ Time Frame: 2 Months ]
    Skin surface roughness will be measured with an optical coherence tomography instrument
  • Age-related changes in skin OAC on the cheek [ Time Frame: 2 Months ]
    Optical Attenuation Coefficient (OAC) will be measured with an optical coherence tomography instrument
  • Age-related changes in skin topography on the cheek [ Time Frame: 2 Months ]
    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).
  • Age-related changes in skin gloss on the cheek [ Time Frame: 2 Months ]
    Skin gloss (Shine and Oiliness) imaged using a camera-based system which uses various lighting/capture modalities to enhance the visualization of skin features
  • Age-related changes in fine lines on the cheek [ Time Frame: 2 Months ]
    The investigator will assess the participant's appearance of fine lines/wrinkles using a 5-point scale from (0=None to 4=Diffuse)
  • Clinical scoring of age-related changes in skin roughness on the cheek [ Time Frame: 2 Months ]
    The investigator will assess the participant's appearance of skin roughness using a 5-point scale from (0=None to 4=Diffuse)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 11, 2020)
  • To evaluate the reliability of skin hydration measurement on the cheek between different time points and different technicians. [ Time Frame: 2 Months ]
  • To evaluate the reliability of different skin elasticity measurement on the cheek between different time points and different technicians. [ Time Frame: 2 Months ]
  • To evaluate the reliability of spectrophotometric skin color measurement on the cheek between different time points and different technicians. [ Time Frame: 2 Months ]
  • To evaluate the reliability of epidermal thickness measurement on the cheek between different time points and different technicians. [ Time Frame: 2 Months ]
  • 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. [ Time Frame: 2 Months ]
  • 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. [ Time Frame: 2 Months ]
  • To evaluate the reliability of skin gloss measurement on the cheek between different technicians. [ Time Frame: 2 Months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Age-related Skin Changes and Instrument Reliability Using Clinical Probe Measurements and Imaging Modalities
Official Title Evaluation of Age-related Skin Changes and Instrument Reliability Using Clinical Probe Measurements and Imaging Modalities
Brief Summary To evaluate the reliability of different non-invasive skin probe measurements.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 200 subjects will be included, with at least 25 subjects per group
Condition Age-related Skin Changes
Intervention Not Provided
Study Groups/Cohorts
  • Group 1
  • Group 2
  • Group 3
  • Group 4
  • Group 5
  • Group 6
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 11, 2020)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 29, 2021
Estimated Primary Completion Date January 29, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Clinical Trials Registry Team 877-277-8566 IR-CTRegistration@Allergan.com
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04552249
Other Study ID Numbers 2019-604-000
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
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/.
Supporting Materials: Study Protocol
Supporting Materials: Clinical Study Report (CSR)
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.
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.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Responsible Party Allergan
Study Sponsor Allergan
Collaborators Not Provided
Investigators
Principal Investigator: Siham Rharbaoui, MD DERMSCAN - Pharmascan
PRS Account Allergan
Verification Date September 2020