Evaluation of Age-Related Skin Changes
16. Juli 2019 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
100
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Villeurbanne, Frankreich, 69100
- Dermscan-Pharmascan
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Weiblich
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
100 female subjects will be included, with at least 10 subjects per age decade
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Age-related changes in fine lines on the cheek
Zeitfenster: 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
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Age-related changes in skin hydration on the cheek
Zeitfenster: 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.
|
4 Months
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Age-related changes in skin hydration on the cheek
Zeitfenster: 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.
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4 Months
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Age-related changes in skin barrier function on the cheek
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 4 Months
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Ultrasound imaging using a Dermascan Ultrasound (Cortex Technology)
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4 Months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Reproducibility and repeatability of the skin hydration measurement on the cheek
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
4 Months
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Reproducibility and repeatability of the skin radiance measurement on the cheek
Zeitfenster: 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
|
4 Months
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Reproducibility and repeatability of the skin color measurement on the cheek
Zeitfenster: 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
Zeitfenster: 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
|
4 Months
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Reproducibility and repeatability of the changes in skin elasticity on the cheek and thigh
Zeitfenster: 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
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Reproducibility and repeatability of the changes in skin thickness and density on the cheek and thigh
Zeitfenster: 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
|
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Reproducibility and repeatability of the changes in skin topography on the cheek
Zeitfenster: 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
Zeitfenster: 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
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Siham Rharbaoui, MD, DERMSCAN - Pharmascan
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
18. April 2019
Primärer Abschluss (Tatsächlich)
12. Juli 2019
Studienabschluss (Tatsächlich)
12. Juli 2019
Studienanmeldedaten
Zuerst eingereicht
24. Januar 2019
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
13. Februar 2019
Zuerst gepostet (Tatsächlich)
15. Februar 2019
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
17. Juli 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
16. Juli 2019
Zuletzt verifiziert
1. Juli 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 2019-602-000
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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