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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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

Condition or disease
Age-related Skin Changes

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Evaluation of Age-related Skin Changes and Instrument Reliability Using Clinical Probe Measurements and Imaging Modalities
Actual Study Start Date : September 22, 2020
Estimated Primary Completion Date : January 29, 2021
Estimated Study Completion Date : January 29, 2021

Group/Cohort
Group 1
Group 2
Group 3
Group 4
Group 5
Group 6



Primary Outcome Measures :
  1. 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.

  2. Age-related changes in skin elasticity on the cheek [ Time Frame: 2 Months ]
    Skin elasticity measurement using suction based device

  3. Age-related changes in skin color on the cheek [ Time Frame: 2 Months ]
    Skin colorimetric measurement will be done with a Spectrophotometer

  4. Age-related changes in skin thickness on the cheek [ Time Frame: 2 Months ]
    Epidermal thickness will be measured with an optical coherence tomography instrument

  5. 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

  6. 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

  7. 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

  8. 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).

  9. 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

  10. 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)

  11. 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)


Secondary Outcome Measures :
  1. To evaluate the reliability of skin hydration measurement on the cheek between different time points and different technicians. [ Time Frame: 2 Months ]
  2. To evaluate the reliability of different skin elasticity measurement on the cheek between different time points and different technicians. [ Time Frame: 2 Months ]
  3. To evaluate the reliability of spectrophotometric skin color measurement on the cheek between different time points and different technicians. [ Time Frame: 2 Months ]
  4. To evaluate the reliability of epidermal thickness measurement on the cheek between different time points and different technicians. [ Time Frame: 2 Months ]
  5. 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 ]
  6. 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 ]
  7. To evaluate the reliability of skin gloss measurement on the cheek between different technicians. [ Time Frame: 2 Months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
200 subjects will be included, with at least 25 subjects per group
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.

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): NCT04552249


Contacts
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Contact: Clinical Trials Registry Team 877-277-8566 IR-CTRegistration@Allergan.com

Locations
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France
Dermscan-Pharmascan Recruiting
Villeurbanne, France, 69100
Contact    +33(0)4 72 89 36 56      
Sponsors and Collaborators
Allergan
Investigators
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Principal Investigator: Siham Rharbaoui, MD DERMSCAN - Pharmascan
Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT04552249    
Other Study ID Numbers: 2019-604-000
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020
Individual Participant Data (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
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

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