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A Study to Evaluate Skin Irritation and Photo Irritation of JNJ 10229570-AAA on Intact Skin of Japanese Healthy Male Participants

2012年10月30日 更新者：Janssen Pharmaceutical K.K.

A Study to Evaluate Skin Irritation and Photo Irritation of JNJ 10229570-AAA on Intact Skin of Japanese Healthy Male Subjects

The purpose of this study is to evaluate skin irritation and photo irritation of JNJ 10229570-AAA on intact skin of Japanese healthy male participants.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This is a single center, interpreter-blinded (the person interpreting the results does not know the name of the assigned drug), randomized (drug is assigned by chance like flipping a coin), vehicle-controlled, closed-patch test study. Thirty (30) Japanese participants will be enrolled in the study. Each treatment (JNJ 10229570-AAA at 1.2%, 2.4%, 3.6%, vehicle in a cream formulation, and petroleum jelly) will be randomly applied in vertical position on the back of each participant, with a corresponding strength applied at the same vertical position (left vs. right). The study drugs applied on the left side will be washed off at 48 hours after application. The dermatological evaluation and photo shoots will be done at 1 (T49) and 24 (T72) hours after washing off the drugs. All participants who completed the dermatological evaluation will be included in the evaluation of skin irritation and skin photo irritation. The study drugs applied on the right side will be washed off at 24 hours after application. The dermatological evaluation and photo shoots will be done at 1 hour after washing off. Ultraviolet A (UVA) will be irradiated to the application site. One hour after irradiation start (T26), the dermatological evaluation and photo shoots will be done. Afterwards the application site will be covered for the protection against UV. Twenty-four hours after washing off (T48), the cover will be taken off, and then the dermatological evaluation and photo shoots will be done at 1 (T49) and 24 (T72) hours. Additionally, the safety profile of JNJ 10229570-AAA will be assessed during the study. The study has a total duration of maximum 32 days.

研究类型

介入性

注册 (实际的)

30

阶段

  • 阶段1

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

  • 日本
      • Fukukoka、日本
      • Hakata、日本

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

20年 至 40年 (成人)

接受健康志愿者

是的

有资格学习的性别

男性

描述

Inclusion Criteria:

  • Signed an informed consent document
  • Body mass index between 18.0 and 30.0 kg/m2 (inclusive), and body weight not less than 50 kg
  • Blood pressure between 90 and 140 mmHg systolic (inclusive), and no higher than 90 mmHg diastolic
  • Electrocardiogram (ECG) consistent with normal cardiac conduction and function
  • Non-smoker
  • Agree to use an adequate contraception method

Exclusion Criteria:

  • History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
  • Clinically significant abnormal values for hematology, biochemistry or urinalysis
  • Clinically significant abnormal physical examination, vital signs or ECG
  • Use of any prescription or nonprescription medication (including vitamins and herbal supplements) within 14 days before the study treatment
  • History of drug or alcohol abuse within the past 5 years
  • Drug allergy or drug hypersensitivity
  • Blood donation, depending on the volume of blood collection
  • Positive test for human immunodeficiency virus (HIV), hepatitis B or C, or syphilis
  • Dermatological disease at application site
  • Photosensitivity
  • Exposure to excessive or chronic ultraviolet (UV) radiation (i.e., sunbathing, tanning salon use, phototherapy) within 4 weeks prior to study treatment or planned during the study period

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

  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Closed-patch test
药品：JNJ 10229570-AAA 1.2% cream
A patch containing the cream will be applied on the back and left for 48 hours on the left side, and 24 hours on the right side.
药品：JNJ 10229570-AAA 2.4% cream
A patch containing the cream will be applied on the back and left for 48 hours on the left side, and 24 hours on the right side.
药品：JNJ 10229570-AAA 3.6% cream
A patch containing the cream will be applied on the back and left for 48 hours on the left side, and 24 hours on the right side.
药品：Color-matched vehicle in a cream formulation containing 0 mg of JNJ 10229570-AAA
A patch containing the cream will be applied on the back and left for 48 hours on the left side, and 24 hours on the right side.
药品：Petroleum jelly
A patch containing the petroleum jelly will be applied on the back and left for 48 hours on the left side, and 24 hours on the right side.

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
Skin irritation according to the Japanese evaluation criteria (scores on a scale)
大体时间：72 hours
The Japanese skin irritation evaluation criteria is a 6-point scale specifying the irritation level of the skin, from 0 (no response) to 4 (blister)
72 hours
Skin photo irritation according to the Japanese evaluation criteria (scores on a scale)
大体时间：72 hours
The Japanese skin photo irritation evaluation criteria is a 6-point scale specifying the level of skin photo irritation from 0 (lack of reaction or reaction comparable to non-irradiated site) to 4 (reaction four ranks more pronouced using domestic criteria compared with non-irradiated site)
72 hours

次要结果测量

结果测量
措施说明
大体时间
Skin irritation according to the International Contact Dermatitis Research Group (ICDRG) criteria (measurements on a scale)
大体时间：72 hours
The ICDRG scale measures the level of skin irritation from Negative (no reaction) to Extreme Positive Reaction (erythema, infiltration, confluent vesicles)
72 hours
Skin photo irritation according to the International Contact Dermatitis Research Group (ICDRG) criteria (measurements on a scale)
大体时间：72 hours
The ICDRG scale measures the level of skin irritation from Negative (no reaction) to Extreme Positive Reaction (erythema, infiltration, confluent vesicles)
72 hours
Number of participants with adverse events as a measure of safety and tolerability
大体时间：32 days
32 days

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。

赞助

Janssen Pharmaceutical K.K.

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

2011年8月1日

初级完成 (实际的)

2011年9月1日

研究完成 (实际的)

2011年9月1日

研究注册日期

首次提交

2011年12月13日

首先提交符合 QC 标准的

2011年12月15日

首次发布 (估计)

2011年12月19日

研究记录更新

最后更新发布 (估计)

2012年10月31日

上次提交的符合 QC 标准的更新

2012年10月30日

最后验证

2012年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CR018670
  • 10229570-JPN-01 (其他标识符：Janssen Pharmaceutical K.K., Japan)

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.

JNJ 10229570-AAA 1.2% cream的临床试验

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赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Peru

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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