Evaluation of Age-Related Skin Changes
2019年7月16日 更新者：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.
調査の概要
状態
完了
条件
研究の種類
観察的
入学 (実際)
100
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Villeurbanne、フランス、69100
- Dermscan-Pharmascan
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～80年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
女性
サンプリング方法
非確率サンプル
調査対象母集団
100 female subjects will be included, with at least 10 subjects per age decade
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Age-related changes in fine lines on the cheek
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：4 Months
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Ultrasound imaging using a Dermascan Ultrasound (Cortex Technology)
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4 Months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Reproducibility and repeatability of the skin hydration measurement on the cheek
時間枠：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
時間枠：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
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Reproducibility and repeatability of the skin barrier function measurement on the cheek
時間枠：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
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Reproducibility and repeatability of the skin radiance measurement on the cheek
時間枠：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
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4 Months
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Reproducibility and repeatability of the skin color measurement on the cheek
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Siham Rharbaoui, MD、DERMSCAN - Pharmascan
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2019年4月18日
一次修了 (実際)
2019年7月12日
研究の完了 (実際)
2019年7月12日
試験登録日
最初に提出
2019年1月24日
QC基準を満たした最初の提出物
2019年2月13日
最初の投稿 (実際)
2019年2月15日
学習記録の更新
投稿された最後の更新 (実際)
2019年7月17日
QC基準を満たした最後の更新が送信されました
2019年7月16日
最終確認日
2019年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2019-602-000
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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