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临床试验/NCT01892423
NCT01892423已完成不适用

Daily Advance Cetaphil Moisturizing Lotion: Human Repeat Insult Patch Test

Galderma R&D1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2006年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Galderma R&D
入组人数
146
试验地点
1
主要终点
Irritation responses

研究概览

简要总结

Human repeat insult patch test to assess the potential for Cetaphil Moisturizing Lotion Daily Advance to induce sensitization to the skin

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age 18-65 years
  • •Good health
  • •willingness to cooperate and participate
  • •willingness to avoid topical products at test sites
  • •willingness to avoid direct sun exposure to test sites

排除标准

  • •Individuals with active psoriasis or eczema
  • •individuals with sunburn, acne, abrasions, scar tissue, or tattoos on test sites, or disease of skin that might interfere
  • •individuals who have had a mastectomy with axillary nodes were removed
  • •individuals receiving anticancer, immunosuppressive treatments or medications, or radiation
  • •pregnant, nursing, or planned to become pregnant
  • •use of topical steroids or drugs at test sites
  • •active or untreated skin cancer
  • •active hepatitis
  • •current routine or frequent use of high doses of anti-inflammatory drugs
  • •individuals who have had les than two week rest period since completion of previous patch testing on upper back or upper arms
  • •individuals with uncontrolled metabolic diseases

研究组 & 干预措施

Cetaphil Moisturizing Lotion Daily Advance

Experimental

Each subject had Cetaphil Moisturizing Lotion Daily Advance applied

干预措施: Cetaphil Moisturizing Lotion Daily Advance (Other)

结局指标

主要结局

Irritation responses

时间窗: average of 5 weeks

all patients will be assessed at 14 visits for redness (erythema), spreading, weeping, papules, vesicles, and bullae at application site

次要结局

未报告次要终点

研究者

发起方
Galderma R&D
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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