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

2019年1月7日 更新者: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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

43

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Valinhos、巴西、13271-130
        • GSK Investigational Site
      • Valinhos、巴西、13271-
        • GSK Investigational Site

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的: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).
实验性的: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).
实验性的: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).
实验性的: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).
假比较器: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).

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Frequency of Dermal Response Score at 15-30 Minutes Post Patch Removal
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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)

次要结果测量

结果测量
措施说明
大体时间
Number of Participants With Combined Skin Irritation (Dermal Response) Scores at 30 Minutes, 24 Hours and 48 Hours Post Patch Removal
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年5月22日

初级完成 (实际的)

2017年5月26日

研究完成 (实际的)

2017年5月26日

研究注册日期

首次提交

2017年7月7日

首先提交符合 QC 标准的

2017年7月25日

首次发布 (实际的)

2017年7月28日

研究记录更新

最后更新发布 (实际的)

2019年1月16日

上次提交的符合 QC 标准的更新

2019年1月7日

最后验证

2018年12月1日

更多信息

与本研究相关的术语

其他研究编号

  • 207235

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

皮肤护理的临床试验

Experimental Daily Defense Serum A的临床试验

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