NCT00591331已完成1 期
Phase 1 Evaluation of the Phototoxic Potential of NatrOVA Creme Rinse - 1% in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- ParaPRO LLC
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Safety endpoint will be visual grading of UV irradiated test sites and assessments of adverse experiences
研究概览
简要总结
This study will evaluate the primary irritation potential of NatrOVA Creme Rinse - 1% in humans, after exposure to UV radiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female subjects 18-65 years of age and in good health.
- •Fitzpatrick skin type I, II or III
排除标准
- •History of severe reactions from exposure to sunlight
- •Known allergies or sensitivities to adhesives in patches
- •Inability to evaluate the skin in and around the test sites
- •Diabetes requiring medication
- •Clinical significant skin disease
- •Asthma or other severe respiratory disease
- •Known immunological disorders such as HIV, AIDS, lupus,rheumatoid arthritis
- •History or current skin cancer
- •Mastectomy for cancer involving removal of lymph nodes draining the test sites
- •Pregnancy, lactation, or planned pregnancy during study period
- •Chronic use of systemic antihistamine medication within 14 days of screening
- •Use of anti-inflammatory drugs within 2 days of Screening Visit 1
- •Currently receiving allergy injections
- •Use of immunosuppressive drugs
- •Topical drugs used at the test site within 7 days of Screening Visit 1
- •Current participation in any clinical trial
- •Participation in any patch test for irritation or sensitization or UV exposures within 4 weeks of study start
- •Use of any investigational drug therapy within 4 weeks of study start.
研究组 & 干预措施
1
Experimental
NatrOVA Creme Rinse - 1%
干预措施: Spinosad (the active ingredient in NatrOVA) (Drug)
2
Experimental
NatrOVA Creme Rinse Vehicle Only
干预措施: Spinosad (the active ingredient in NatrOVA) (Drug)
3
Placebo Comparator
Blank patch
干预措施: placebo (Drug)
结局指标
主要结局
Safety endpoint will be visual grading of UV irradiated test sites and assessments of adverse experiences
时间窗: 7 days
次要结局
未报告次要终点
研究者
研究点 (1)
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