Age-related Skin ChangesNCT04552249
Evaluation of Age-related Skin Changes and Instrument Reliability Using Clinical Probe Measurements and Imaging Modalities
An observational study of Age-related Skin Changes, run by Allergan at 1 site in France.
Trial summary
To evaluate the reliability of different non-invasive skin probe measurements. Read more about this study
- Who is it for?
- Ages 20 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-related Skin Changes
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 22 Sep 2020to 18 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 200 subjects will be included, with at least 25 subjects per group
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the reliability of different non-invasive skin probe measurements.
- Conditions
- Age-related Skin Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described | |
| Group 2 | Not described | |
| Group 3 | Not described | |
| Group 4 | Not described | |
| Group 5 | Not described | |
| Group 6 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 Months
Age-related changes in skin elasticity on the cheek
Skin elasticity measurement using suction based device
Measured: 2 Months
Age-related changes in skin color on the cheek
Skin colorimetric measurement will be done with a Spectrophotometer
Measured: 2 Months
Age-related changes in skin thickness on the cheek
Epidermal thickness will be measured with an optical coherence tomography instrument
Measured: 2 Months
Age-related changes in skin blood flow on the cheek
Blood Flow (redness) will be measured with an optical coherence tomography instrument
Measured: 2 Months
Age-related changes in skin roughness on the cheek
Skin surface roughness will be measured with an optical coherence tomography instrument
Measured: 2 Months
Age-related changes in skin OAC on the cheek
Optical Attenuation Coefficient (OAC) will be measured with an optical coherence tomography instrument
Measured: 2 Months
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).
Measured: 2 Months
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
Measured: 2 Months
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)
Measured: 2 Months
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)
Measured: 2 Months
Secondary outcomes (7)
To evaluate the reliability of skin hydration measurement on the cheek between different time points and different technicians.
Measured: 2 Months
To evaluate the reliability of different skin elasticity measurement on the cheek between different time points and different technicians.
Measured: 2 Months
To evaluate the reliability of spectrophotometric skin color measurement on the cheek between different time points and different technicians.
Measured: 2 Months
To evaluate the reliability of epidermal thickness measurement on the cheek between different time points and different technicians.
Measured: 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.
Measured: 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.
Measured: 2 Months
To evaluate the reliability of skin gloss measurement on the cheek between different technicians.
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start22 Sep 2020
- Primary completion18 Dec 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Skin ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Siham Rharbaoui, MD, Principal investigator, DERMSCAN - Pharmascan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552249
- Sponsor's protocol ID
- 2019-604-000
- Status last verified
- Mar 2021
- First submitted
- 11 Sep 2020
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Age-related Skin Changes and Instrument Reliability Using Clinical Probe Measurements and Imaging Modalities
- ClinicalTrials.gov ID
- NCT04552249
- Acronym / sponsor ID
- 2019-604-000
- Conditions
- Age-related Skin Changes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the reliability of different non-invasive skin probe measurements.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | – |
| Group 2 | – | – |
| Group 3 | – | – |
| Group 4 | – | – |
| Group 5 | – | – |
| Group 6 | – | – |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 200 subjects will be included, with at least 25 subjects per group
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- 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 assistanceLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siham Rharbaoui, MD principal investigator
DERMSCAN - Pharmascan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-related Skin Changes, run by Allergan at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age-related changes in skin hydration on the cheek (time frame: 2 Months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.