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

March 5, 2021 updated by: Allergan
To evaluate the reliability of different non-invasive skin probe measurements.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Villeurbanne, France, 69100
        • Dermscan-Pharmascan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

200 subjects will be included, with at least 25 subjects per group

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Group 1
Group 2
Group 3
Group 4
Group 5
Group 6

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 Months
Age-related changes in skin elasticity on the cheek
Time Frame: 2 Months
Skin elasticity measurement using suction based device
2 Months
Age-related changes in skin color on the cheek
Time Frame: 2 Months
Skin colorimetric measurement will be done with a Spectrophotometer
2 Months
Age-related changes in skin thickness on the cheek
Time Frame: 2 Months
Epidermal thickness will be measured with an optical coherence tomography instrument
2 Months
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
2 Months
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
2 Months
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
2 Months
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).
2 Months
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
2 Months
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)
2 Months
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)
2 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
To evaluate the reliability of skin hydration measurement on the cheek between different time points and different technicians.
Time Frame: 2 Months
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
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
2 Months
To evaluate the reliability of epidermal thickness measurement on the cheek between different time points and different technicians.
Time Frame: 2 Months
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
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
2 Months
To evaluate the reliability of skin gloss measurement on the cheek between different technicians.
Time Frame: 2 Months
2 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allergan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Siham Rharbaoui, MD, DERMSCAN - Pharmascan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 22, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 18, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 18, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-604-000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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/.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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