An Evaluation of the Photoallergy Potential of NatrOVA Creme Rinse - 1% in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- ParaPRO LLC
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Visual grading of test site and assessments of adverse experiences
研究概览
简要总结
Photoallergic reactions are assumed to be due to a delayed cell-mediated hypersensitivity response that requires the presence of ultraviolet irradiation. The predictive procedure is, therefore, based on modification of the Repeated Insult Patch Test (Kaidbey, 1991). Duplicate sets of patches of test articles are used with exposure of only one set to UV radiation and subsequent evaluation of both sets for skin reactions in order to compare irradiated versus non-irradiated test sites.
详细描述
The study consists of of following phases: screening, induction, rest, challenge, and re-challenge (if necessary). The study will be conducted as a randomized, evaluator-blind test design.
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
- Double (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
- •Has the ability to understand and has signed a written informed consent form and HIPAA authorization
- •Females of childbearing potential must agree to use an adequate birth control
- •Fitzpatrick (1988) 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, medical tape, or ingredients found in the test articles
- •Inability to evaluate the skin in and around the test sites
- •Diabetes requiring medication
- •Clinical significant skin diseases which may contraindicate participation
- •Asthma or any other severe respiratory disease requiring chronic medication
- •Known immunological disorders such as HIV, AIDS, SLE and/or RA
- •History, within the last six months, of current cancer, including skin cancer
- •Mastectomy for cancer removal of lymph nodes draining test sites
- •Pregnancy, lactation, or planning a pregnancy during the test period
- •Chronic use of systemic antihistamine medication, or use within 14 days prior to Screening Visit
- •Use of anti-inflammatory drugs (exception: acetaminophen and < 81 mg.day aspirin are permitted) within 2 days of Screening Visit
- •Currently receiving allergy injections
- •Currently taking or expecting to take any photosensitizing medications
- •Use of immunosuppressive drugs
- •Topical drugs used at the test sites within the last 7 days prior to screening
- •Current participation in any clinical trial
- •Participation in any patch test for irritation or sensitization or any test involving UV exposures within 4 wees of study start
- •Use of any investigational therapy within the past 4 weeks.
研究组 & 干预措施
3
Blank Patch
干预措施: Blank Patch (Drug)
1
NatrOVA Creme Rinse - 1% Spinosad
干预措施: NatrOVA Creme Rinse - 1% (Drug)
2
NatrOVA Vehicle - no Spinosad
干预措施: NatrOVA Creme Rinse Vehicle Only (Drug)
结局指标
主要结局
Visual grading of test site and assessments of adverse experiences
时间窗: Evaluations over a 6 week period
次要结局
未报告次要终点