Age-related Skin ChangesNCT03842566
Evaluation of Age-Related Skin Changes
An observational study of Age-related Skin Changes, run by Allergan at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Age-related Skin Changes
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 18 Apr 2019to 12 Jul 2019
- 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 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 100 female subjects will be included, with at least 10 subjects per age decade
Who may be able to join
- 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.
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.
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Age-Related Skin Changes Using Clinical Probe Measurements and Imaging
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.
- 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 |
|---|---|---|
| 20-29 Years Old | Not described | |
| 30-39 Years Old | Not described | |
| 40-49 Years Old | Not described | |
| 50-59 Years Old | Not described | |
| 60-69 Years Old | Not described | |
| 70-79 Years Old | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age-related changes in fine lines on the cheek
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).
Measured: 4 Months
Age-related changes in skin hydration on the cheek
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.
Measured: 4 Months
Age-related changes in skin hydration on the cheek
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.
Measured: 4 Months
Age-related changes in skin barrier function on the cheek
Transepidermal water loss measurement using an AquaFlux AF100 (Biox Systems Ltd)
Measured: 4 Months
Age-related changes in skin radiance on the cheek
Measurement of light reflection using a Skin-Glossymeter GL200 (Courage \& Khazaka)
Measured: 4 Months
Age-related changes in skin color on the cheek
Skin colorimetric measurement using a Spectrophotometer (Konica Minolta)
Measured: 4 Months
Age-related changes in skin melanin on the cheek
Colorimetric measurement of skin melanin using a Mexameter MX18 (Courage \& Khazaka)
Measured: 4 Months
Age-related changes in skin elasticity on the cheek and thigh
Skin elasticity measurement using a Cutometer (Courage \& Khazaka), ElastiMeter (Delfin Technologies), and Dermal Torque Meter (Dia-Stron Limited)
Measured: 4 Months
Age-related changes in skin thickness on the cheek and thigh
Ultrasound imaging using a Dermascan Ultrasound (Cortex Technology)
Measured: 4 Months
Age-related changes in skin topography on the cheek and thigh
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).
Measured: 4 Months
Age-related changes in skin topography on the cheek and thigh
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).
Measured: 4 Months
Age-related changes in skin density on the cheek and thigh
Ultrasound imaging using a Dermascan Ultrasound (Cortex Technology)
Measured: 4 Months
Secondary outcomes (10)
Reproducibility and repeatability of the skin hydration measurement on the cheek
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
Measured: 4 Months
Reproducibility and repeatability of the skin hydration measurement on the cheek
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
Measured: 4 Months
Reproducibility and repeatability of the skin barrier function measurement on the cheek
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
Measured: 4 Months
Reproducibility and repeatability of the skin radiance measurement on the cheek
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
Measured: 4 Months
Reproducibility and repeatability of the skin color measurement on the cheek
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
Measured: 4 Months
Reproducibility and repeatability of the skin melanin changes on the cheek
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
Measured: 4 Months
Reproducibility and repeatability of the changes in skin elasticity on the cheek and thigh
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
Measured: 4 Months
Reproducibility and repeatability of the changes in skin thickness and density on the cheek and thigh
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
Measured: 4 Months
Reproducibility and repeatability of the changes in skin topography on the cheek
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
Measured: 4 Months
Reproducibility and repeatability of the changes in skin topography on the cheek
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
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start18 Apr 2019
- Primary completion12 Jul 2019
- Study completion12 Jul 2019
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
- 100 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
- NCT03842566
- Sponsor's protocol ID
- 2019-602-000
- Status last verified
- Jul 2019
- First submitted
- 24 Jan 2019
- Last updated
- 17 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Age-Related Skin Changes Using Clinical Probe Measurements and Imaging
- ClinicalTrials.gov ID
- NCT03842566
- Acronym / sponsor ID
- 2019-602-000
- Conditions
- Age-related Skin Changes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- 12 Jul 2019 (actual)
- Study completion
- 12 Jul 2019 (actual)
- First posted
- 15 Feb 2019 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 20-29 Years Old | – | – |
| 30-39 Years Old | – | – |
| 40-49 Years Old | – | – |
| 50-59 Years Old | – | – |
| 60-69 Years Old | – | – |
| 70-79 Years Old | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 100 female subjects will be included, with at least 10 subjects per age decade
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 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.
- 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.
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 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).
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.
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.
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)
Age-related changes in skin radiance on the cheek
Time frame: 4 Months
Measurement of light reflection using a Skin-Glossymeter GL200 (Courage \& Khazaka)
Age-related changes in skin color on the cheek
Time frame: 4 Months
Skin colorimetric measurement using a Spectrophotometer (Konica Minolta)
Age-related changes in skin melanin on the cheek
Time frame: 4 Months
Colorimetric measurement of skin melanin using a Mexameter MX18 (Courage \& Khazaka)
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)
Age-related changes in skin thickness on the cheek and thigh
Time frame: 4 Months
Ultrasound imaging using a Dermascan Ultrasound (Cortex Technology)
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).
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).
Age-related changes in skin density on the cheek and thigh
Time frame: 4 Months
Ultrasound imaging using a Dermascan Ultrasound (Cortex Technology)
10 secondary outcomes
Reproducibility and repeatability of the skin hydration measurement on the cheek
Time frame: 4 Months
Reproducibility and repeatability of the skin hydration measurement on the cheek
Time frame: 4 Months
Reproducibility and repeatability of the skin barrier function measurement on the cheek
Time frame: 4 Months
Reproducibility and repeatability of the skin radiance measurement on the cheek
Time frame: 4 Months
Reproducibility and repeatability of the skin color measurement on the cheek
Time frame: 4 Months
Reproducibility and repeatability of the skin melanin changes on the cheek
Time frame: 4 Months
Reproducibility and repeatability of the changes in skin elasticity on the cheek and thigh
Time frame: 4 Months
Reproducibility and repeatability of the changes in skin thickness and density on the cheek and thigh
Time frame: 4 Months
Reproducibility and repeatability of the changes in skin topography on the cheek
Time frame: 4 Months
Reproducibility and repeatability of the changes in skin topography on the cheek
Time frame: 4 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 17 Jul 2019.
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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 9 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 17 Jul 2019. 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 fine lines on the cheek (time frame: 4 Months). The study lists 12 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 17 Jul 2019.