Evaluation of Age-Related Skin Changes
16. července 2019 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Typ studie
Pozorovací
Zápis (Aktuální)
100
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Villeurbanne, Francie, 69100
- Dermscan-Pharmascan
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 80 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Ženský
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
100 female subjects will be included, with at least 10 subjects per age decade
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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20-29 Years Old
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30-39 Years Old
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40-49 Years Old
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50-59 Years Old
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60-69 Years Old
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70-79 Years Old
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Age-related changes in fine lines on the cheek
Časové okno: 4 Months
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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
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Age-related changes in skin hydration on the cheek
Časové okno: 4 Months
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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.
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4 Months
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Age-related changes in skin hydration on the cheek
Časové okno: 4 Months
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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.
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4 Months
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Age-related changes in skin barrier function on the cheek
Časové okno: 4 Months
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Transepidermal water loss measurement using an AquaFlux AF100 (Biox Systems Ltd)
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4 Months
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Age-related changes in skin radiance on the cheek
Časové okno: 4 Months
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Measurement of light reflection using a Skin-Glossymeter GL200 (Courage & Khazaka)
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4 Months
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Age-related changes in skin color on the cheek
Časové okno: 4 Months
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Skin colorimetric measurement using a Spectrophotometer (Konica Minolta)
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4 Months
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Age-related changes in skin melanin on the cheek
Časové okno: 4 Months
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Colorimetric measurement of skin melanin using a Mexameter MX18 (Courage & Khazaka)
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4 Months
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Age-related changes in skin elasticity on the cheek and thigh
Časové okno: 4 Months
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Skin elasticity measurement using a Cutometer (Courage & Khazaka), ElastiMeter (Delfin Technologies), and Dermal Torque Meter (Dia-Stron Limited)
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4 Months
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Age-related changes in skin thickness on the cheek and thigh
Časové okno: 4 Months
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Ultrasound imaging using a Dermascan Ultrasound (Cortex Technology)
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4 Months
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Age-related changes in skin topography on the cheek and thigh
Časové okno: 4 Months
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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).
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4 Months
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Age-related changes in skin topography on the cheek and thigh
Časové okno: 4 Months
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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).
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4 Months
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Age-related changes in skin density on the cheek and thigh
Časové okno: 4 Months
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Ultrasound imaging using a Dermascan Ultrasound (Cortex Technology)
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4 Months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Reproducibility and repeatability of the skin hydration measurement on the cheek
Časové okno: 4 Months
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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
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4 Months
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Reproducibility and repeatability of the skin hydration measurement on the cheek
Časové okno: 4 Months
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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
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4 Months
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Reproducibility and repeatability of the skin barrier function measurement on the cheek
Časové okno: 4 Months
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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
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4 Months
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Reproducibility and repeatability of the skin radiance measurement on the cheek
Časové okno: 4 Months
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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
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4 Months
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Reproducibility and repeatability of the skin color measurement on the cheek
Časové okno: 4 Months
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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
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Reproducibility and repeatability of the skin melanin changes on the cheek
Časové okno: 4 Months
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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
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4 Months
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Reproducibility and repeatability of the changes in skin elasticity on the cheek and thigh
Časové okno: 4 Months
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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
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4 Months
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Reproducibility and repeatability of the changes in skin thickness and density on the cheek and thigh
Časové okno: 4 Months
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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
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Reproducibility and repeatability of the changes in skin topography on the cheek
Časové okno: 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
|
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Reproducibility and repeatability of the changes in skin topography on the cheek
Časové okno: 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
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4 Months
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Siham Rharbaoui, MD, DERMSCAN - Pharmascan
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
18. dubna 2019
Primární dokončení (Aktuální)
12. července 2019
Dokončení studie (Aktuální)
12. července 2019
Termíny zápisu do studia
První předloženo
24. ledna 2019
První předloženo, které splnilo kritéria kontroly kvality
13. února 2019
První zveřejněno (Aktuální)
15. února 2019
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
17. července 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
16. července 2019
Naposledy ověřeno
1. července 2019
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 2019-602-000
Informace o lécích a zařízeních, studijní dokumenty
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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