Evaluation of Age-Related Skin Changes
16 juli 2019 bijgewerkt door: Allergan
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Studietype
Observationeel
Inschrijving (Werkelijk)
100
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
-
Villeurbanne, Frankrijk, 69100
- Dermscan-Pharmascan
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 80 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Vrouw
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
100 female subjects will be included, with at least 10 subjects per age decade
Beschrijving
Inclusion Criteria:
- 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.
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.
- 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.
- 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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
20-29 Years Old
|
|
30-39 Years Old
|
|
40-49 Years Old
|
|
50-59 Years Old
|
|
60-69 Years Old
|
|
70-79 Years Old
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Age-related changes in fine lines on the cheek
Tijdsspanne: 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). |
4 Months
|
|
Age-related changes in skin hydration on the cheek
Tijdsspanne: 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.
|
4 Months
|
|
Age-related changes in skin hydration on the cheek
Tijdsspanne: 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.
|
4 Months
|
|
Age-related changes in skin barrier function on the cheek
Tijdsspanne: 4 Months
|
Transepidermal water loss measurement using an AquaFlux AF100 (Biox Systems Ltd)
|
4 Months
|
|
Age-related changes in skin radiance on the cheek
Tijdsspanne: 4 Months
|
Measurement of light reflection using a Skin-Glossymeter GL200 (Courage & Khazaka)
|
4 Months
|
|
Age-related changes in skin color on the cheek
Tijdsspanne: 4 Months
|
Skin colorimetric measurement using a Spectrophotometer (Konica Minolta)
|
4 Months
|
|
Age-related changes in skin melanin on the cheek
Tijdsspanne: 4 Months
|
Colorimetric measurement of skin melanin using a Mexameter MX18 (Courage & Khazaka)
|
4 Months
|
|
Age-related changes in skin elasticity on the cheek and thigh
Tijdsspanne: 4 Months
|
Skin elasticity measurement using a Cutometer (Courage & Khazaka), ElastiMeter (Delfin Technologies), and Dermal Torque Meter (Dia-Stron Limited)
|
4 Months
|
|
Age-related changes in skin thickness on the cheek and thigh
Tijdsspanne: 4 Months
|
Ultrasound imaging using a Dermascan Ultrasound (Cortex Technology)
|
4 Months
|
|
Age-related changes in skin topography on the cheek and thigh
Tijdsspanne: 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).
|
4 Months
|
|
Age-related changes in skin topography on the cheek and thigh
Tijdsspanne: 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).
|
4 Months
|
|
Age-related changes in skin density on the cheek and thigh
Tijdsspanne: 4 Months
|
Ultrasound imaging using a Dermascan Ultrasound (Cortex Technology)
|
4 Months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Reproducibility and repeatability of the skin hydration measurement on the cheek
Tijdsspanne: 4 Months
|
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
|
4 Months
|
|
Reproducibility and repeatability of the skin hydration measurement on the cheek
Tijdsspanne: 4 Months
|
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
|
4 Months
|
|
Reproducibility and repeatability of the skin barrier function measurement on the cheek
Tijdsspanne: 4 Months
|
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
|
4 Months
|
|
Reproducibility and repeatability of the skin radiance measurement on the cheek
Tijdsspanne: 4 Months
|
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
|
4 Months
|
|
Reproducibility and repeatability of the skin color measurement on the cheek
Tijdsspanne: 4 Months
|
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
|
4 Months
|
|
Reproducibility and repeatability of the skin melanin changes on the cheek
Tijdsspanne: 4 Months
|
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
|
4 Months
|
|
Reproducibility and repeatability of the changes in skin elasticity on the cheek and thigh
Tijdsspanne: 4 Months
|
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
|
4 Months
|
|
Reproducibility and repeatability of the changes in skin thickness and density on the cheek and thigh
Tijdsspanne: 4 Months
|
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
|
4 Months
|
|
Reproducibility and repeatability of the changes in skin topography on the cheek
Tijdsspanne: 4 Months
|
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
|
4 Months
|
|
Reproducibility and repeatability of the changes in skin topography on the cheek
Tijdsspanne: 4 Months
|
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
|
4 Months
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Siham Rharbaoui, MD, DERMSCAN - Pharmascan
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
18 april 2019
Primaire voltooiing (Werkelijk)
12 juli 2019
Studie voltooiing (Werkelijk)
12 juli 2019
Studieregistratiedata
Eerst ingediend
24 januari 2019
Eerst ingediend dat voldeed aan de QC-criteria
13 februari 2019
Eerst geplaatst (Werkelijk)
15 februari 2019
Updates van studierecords
Laatste update geplaatst (Werkelijk)
17 juli 2019
Laatste update ingediend die voldeed aan QC-criteria
16 juli 2019
Laatst geverifieerd
1 juli 2019
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 2019-602-000
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .