연령 관련 피부 변화에 대한 임상 시험 - 임상 시험 레지스트리

연구 개요

상태

완전한

정황

연령 관련 피부 변화

연구 유형

관찰

등록 (실제)

100

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

프랑스
- - Villeurbanne, 프랑스, 69100
    - Dermscan-Pharmascan

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

여성

샘플링 방법

비확률 샘플

연구 인구

100 female subjects will be included, with at least 10 subjects per age decade

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

그룹/코호트 수

6

코호트 및 개입

그룹/코호트
20-29 Years Old
30-39 Years Old
40-49 Years Old
50-59 Years Old
60-69 Years Old
70-79 Years Old

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Age-related changes in fine lines on the cheek 기간: 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 기간: 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 기간: 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 기간: 4 Months	Transepidermal water loss measurement using an AquaFlux AF100 (Biox Systems Ltd)	4 Months
Age-related changes in skin radiance on the cheek 기간: 4 Months	Measurement of light reflection using a Skin-Glossymeter GL200 (Courage & Khazaka)	4 Months
Age-related changes in skin color on the cheek 기간: 4 Months	Skin colorimetric measurement using a Spectrophotometer (Konica Minolta)	4 Months
Age-related changes in skin melanin on the cheek 기간: 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 기간: 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 기간: 4 Months	Ultrasound imaging using a Dermascan Ultrasound (Cortex Technology)	4 Months
Age-related changes in skin topography on the cheek and thigh 기간: 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 기간: 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 기간: 4 Months	Ultrasound imaging using a Dermascan Ultrasound (Cortex Technology)	4 Months

2차 결과 측정

결과 측정	측정값 설명	기간
Reproducibility and repeatability of the skin hydration measurement on the cheek 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Allergan

수사관

수석 연구원: Siham Rharbaoui, MD, DERMSCAN - Pharmascan

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 4월 18일

기본 완료 (실제)

2019년 7월 12일

연구 완료 (실제)

2019년 7월 12일

연구 등록 날짜

최초 제출

2019년 1월 24일

QC 기준을 충족하는 최초 제출

2019년 2월 13일

처음 게시됨 (실제)

2019년 2월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 7월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 7월 16일

마지막으로 확인됨

2019년 7월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

2019-602-000

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Evaluation of Age-Related Skin Changes

Evaluation of Age-Related Skin Changes Using Clinical Probe Measurements and Imaging