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To Investigate Primary Irritation Potential of Four Skin Serum Products on Human Subjects Assessed by 24 Hour Patch Test

2019년 1월 7일 업데이트: GlaxoSmithKline

A Human Subject 24 Hour Patch Test to Assess the Irritation Potential of Four Skin Serum Products

To assess the irritation potential of four prototype daily defense serum formulations after 24 (± 2) hours under semi-occlusive patch application to the skin of healthy volunteers.

연구 개요

상세 설명

This is an evaluator (single) blind, test site randomized and intra-subject comparison patch test study to evaluate the cutaneous irritation potential of four experimental daily defense serum formulations, including a saline solution as a negative control.

연구 유형

중재적

등록 (실제)

43

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

      • Valinhos, 브라질, 13271-130
        • GSK Investigational Site
      • Valinhos, 브라질, 13271-
        • GSK Investigational Site

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

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
  • General health: Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination and participants must have intact skin on the proposed application site; dorsum (scapular region).
  • Fitzpatrick photo type I to IV.
  • Agreement to comply with the procedures and requirements of the study and to attend the scheduled assessment visits.

Exclusion Criteria:

  • Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
  • Women who are breast-feeding.
  • Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction.
  • Presence of open sores, pimples, or cysts at the application site.
  • Active dermatosis (local or disseminated) that might interfere with the results of the study
  • Considered immune compromised.
  • History of diseases aggravated or triggered by ultraviolet radiation.
  • Participants with dermatographism.
  • Currently using any medication which in the opinion of the investigator, may affect the evaluation of the study product, or place the participant at undue risk.
  • Use of the following topical or systemic medications: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs, and corticosteroids up to 2 weeks before Screening visit.
  • Oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit.
  • Intention of being vaccinated during the study period or vaccination within 3 weeks of the Screening visit.
  • Currently receiving allergy injections, or due to receive an injection within 7 days prior to Visit 1, or expects to begin injections during study participation.
  • Previous history of atopy, allergic reactions, irritation or intense discomfort feelings to topical-use products, cosmetics or medication.
  • Known or suspected intolerance or hypersensitivity to any of the study materials (or closely related compounds) or any of their stated ingredients, including any component of the patches.
  • History of sensitization in a previous patch study.
  • Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the Screening visit.
  • Previous participation in this study.
  • Recent history (within the last 5 years) of alcohol or other substance abuse.
  • Intense sunlight exposure or sun tanning sessions up to 30 days before the Screening evaluation Intention of bathing, sauna, water sports, or activities that lead to intense sweating.
  • Any participant who, in the judgment of the Investigator, should not participate in the study.
  • Any skin marks on the test site that might interfere with the evaluation of possible skin reactions (e.g. pigmentation disorders, vascular malformations, scars, tattoos, excessive hair, numerous freckles).
  • Prisoner or involuntary incarcerated participant.
  • Participant from an indigenous tribe.
  • An employee of the sponsor or the study site or members of their immediate family.

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 기초 과학
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Test Product 1
Participants will topically apply test product 1 via semi occlusive patch.
Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).
실험적: Test Product 2
Participants will topically apply test product 2 via semi occlusive patch.
Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).
실험적: Test Product 3
Participants will topically apply test product 3 via semi occlusive patch.
Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).
실험적: Test Product 4
Participants will topically apply test product 4 via semi occlusive patch.
Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).
가짜 비교기: Reference Product
Participants will topically apply Reference product via semi occlusive patch.
Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Frequency of Dermal Response Score at 15-30 Minutes Post Patch Removal
기간: At Day 2 (15-30 minutes post patch removal)
Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 15-30 minutes following patch removal on Day 2 post 24 hrs of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.
At Day 2 (15-30 minutes post patch removal)
Frequency of Dermal Response Score at 24 Hours Post Patch Removal
기간: At Day 3 (24 hours post patch removal)
Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 24 hours following patch removal on Day 3 post 48 hrs of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.
At Day 3 (24 hours post patch removal)
Frequency of Dermal Response Score at 48 Hours Post Patch Removal
기간: At Day 4 (48 hours post patch removal)
Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 48 hours following patch removal on Day 4 post 72 hours of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.
At Day 4 (48 hours post patch removal)
Average Dermal Response Score at 30 Minutes Post Patch Removal
기간: At Day 2 (15-30 minutes post patch removal)
Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 15-30 minutes following patch removal on Day 2 post 24 hours of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.
At Day 2 (15-30 minutes post patch removal)
Average Dermal Response Score at 24 Hours Post Patch Removal
기간: At Day 3 (24 hours post patch removal)
Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 24 hours following patch removal on Day 3 post 48 hours of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.
At Day 3 (24 hours post patch removal)
Average Dermal Response Score at 48 Hours Post Patch Removal
기간: At Day 4 (48 hours post patch removal)
Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 48 hours following patch removal on Day 4 post 72 hours of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.
At Day 4 (48 hours post patch removal)

2차 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With Combined Skin Irritation (Dermal Response) Scores at 30 Minutes, 24 Hours and 48 Hours Post Patch Removal
기간: At Day 2 (15-30 minutes), Day 3 (24 hours) and Day 4 (48 hours) post patch removal
A trained assessor assessed all patch sites.Following scores were used to express response observed at time of examination:0=No evidence of irritation,1=Minimal erythema;barely perceptible,2=Definite erythema,readily visible;or minimal edema; or minimal papular response,3=Erythema and papules,4=Definite edema,5=Erythema, edema,and papules,6=Vesicular eruption,7=Strong reaction spreading beyond test site.Other features indicative irritation (Superficial irritation) scores were:GradeA/Score0=Slight glazed appearance,GradeB/Score1=Marked glazing,GradeC/Score2=Glazing with peeling and cracking,GradeF/Score3=Glazing with fissures,Grade G/Score 3=Film of dried serous exudate covering all or portion of patch,Grade H/Score3=Small petechial erosions and/or scabs.The letter grades were converted to scores.Superficial irritation scores were only provided if there was a dermal response score >0.No effect is 0 score(i.e. no evidence).Full Range 0-10.Lower score indicates better product tolerabily
At Day 2 (15-30 minutes), Day 3 (24 hours) and Day 4 (48 hours) post patch removal

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스폰서

간행물 및 유용한 링크

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유용한 링크

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)

2017년 5월 22일

기본 완료 (실제)

2017년 5월 26일

연구 완료 (실제)

2017년 5월 26일

연구 등록 날짜

최초 제출

2017년 7월 7일

QC 기준을 충족하는 최초 제출

2017년 7월 25일

처음 게시됨 (실제)

2017년 7월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 1월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 1월 7일

마지막으로 확인됨

2018년 12월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 207235

개별 참가자 데이터(IPD) 계획

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약물 및 장치 정보, 연구 문서

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피부 관리에 대한 임상 시험

Experimental Daily Defense Serum A에 대한 임상 시험

구독하다