Evaluation of Age-Related Skin Changes
16 de julho de 2019 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Observacional
Inscrição (Real)
100
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Villeurbanne, França, 69100
- Dermscan-Pharmascan
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 80 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Fêmea
Método de amostragem
Amostra Não Probabilística
População do estudo
100 female subjects will be included, with at least 10 subjects per age decade
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Age-related changes in fine lines on the cheek
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 4 Months
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Ultrasound imaging using a Dermascan Ultrasound (Cortex Technology)
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4 Months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Reproducibility and repeatability of the skin hydration measurement on the cheek
Prazo: 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
|
4 Months
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Reproducibility and repeatability of the skin hydration measurement on the cheek
Prazo: 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
|
4 Months
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Reproducibility and repeatability of the skin barrier function measurement on the cheek
Prazo: 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
Prazo: 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
Prazo: 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
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4 Months
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Reproducibility and repeatability of the skin melanin changes on the cheek
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 4 Months
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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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Siham Rharbaoui, MD, DERMSCAN - Pharmascan
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
18 de abril de 2019
Conclusão Primária (Real)
12 de julho de 2019
Conclusão do estudo (Real)
12 de julho de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
24 de janeiro de 2019
Enviado pela primeira vez que atendeu aos critérios de CQ
13 de fevereiro de 2019
Primeira postagem (Real)
15 de fevereiro de 2019
Atualizações de registro de estudo
Última Atualização Postada (Real)
17 de julho de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
16 de julho de 2019
Última verificação
1 de julho de 2019
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 2019-602-000
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
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Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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