Evaluation of Age-Related Skin Changes
16 juli 2019 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Observationell
Inskrivning (Faktisk)
100
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Villeurbanne, Frankrike, 69100
- Dermscan-Pharmascan
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Testmetod
Icke-sannolikhetsprov
Studera befolkning
100 female subjects will be included, with at least 10 subjects per age decade
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
20-29 Years Old
|
|
30-39 Years Old
|
|
40-49 Years Old
|
|
50-59 Years Old
|
|
60-69 Years Old
|
|
70-79 Years Old
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Age-related changes in fine lines on the cheek
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 4 Months
|
Transepidermal water loss measurement using an AquaFlux AF100 (Biox Systems Ltd)
|
4 Months
|
|
Age-related changes in skin radiance on the cheek
Tidsram: 4 Months
|
Measurement of light reflection using a Skin-Glossymeter GL200 (Courage & Khazaka)
|
4 Months
|
|
Age-related changes in skin color on the cheek
Tidsram: 4 Months
|
Skin colorimetric measurement using a Spectrophotometer (Konica Minolta)
|
4 Months
|
|
Age-related changes in skin melanin on the cheek
Tidsram: 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
Tidsram: 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
Tidsram: 4 Months
|
Ultrasound imaging using a Dermascan Ultrasound (Cortex Technology)
|
4 Months
|
|
Age-related changes in skin topography on the cheek and thigh
Tidsram: 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
Tidsram: 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
Tidsram: 4 Months
|
Ultrasound imaging using a Dermascan Ultrasound (Cortex Technology)
|
4 Months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Reproducibility and repeatability of the skin hydration measurement on the cheek
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Siham Rharbaoui, MD, DERMSCAN - Pharmascan
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
18 april 2019
Primärt slutförande (Faktisk)
12 juli 2019
Avslutad studie (Faktisk)
12 juli 2019
Studieregistreringsdatum
Först inskickad
24 januari 2019
Först inskickad som uppfyllde QC-kriterierna
13 februari 2019
Första postat (Faktisk)
15 februari 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 juli 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 juli 2019
Senast verifierad
1 juli 2019
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2019-602-000
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .