A Randomized Study to Assess the Potential for Photoallergy of SPF 50 Y65 110, SPF 50 Y51 002 and SPF 15 V27 104 in Human Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 56
- 主要终点
- Evaluation of inflammatory responses
研究概览
简要总结
The primary objective of this tudy was to evaluate the potential of photoallergy of of sun care products Sun Protection Factor (SPF) 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 application compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.
The secondary objective aims for evaluation of the safety of SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 combined with ultraviolet (UV) A/B irradiation by monitoring adverse events (AEs) throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Men or women, aged 18 to 65 with good general health
- •Fitzpatrick skin type I IV
- •Females (of childbearing potential) on acceptable measure of contraception
- •Willing to follow study rules, which include: no sun exposure (for example, no swimming, sunbathing, or tanning beds), avoidance of activities that would cause excessive sweating, no use of lotions, creams, or oils on the back area
- •Willing to not change the current brand of personal care products such as soaps, body washes, laundry detergent, body sprays, body spritzes, etc. while participating in the study
排除标准
- 未提供
研究组 & 干预措施
SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104
All test products compared to that of a negative control [0.9% NaCl] were tested simultaneously on each subject.
干预措施: SPF 50 Y65 110 (BAY987519) (Drug)
SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104
All test products compared to that of a negative control [0.9% NaCl] were tested simultaneously on each subject.
干预措施: SPF 50 Y51 002 (BAY987519) (Drug)
SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104
All test products compared to that of a negative control [0.9% NaCl] were tested simultaneously on each subject.
干预措施: SPF 15 V27 104 (BAY987519) (Drug)
SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104
All test products compared to that of a negative control [0.9% NaCl] were tested simultaneously on each subject.
干预措施: Sodium chloride [NaCl] (Drug)
结局指标
主要结局
Evaluation of inflammatory responses
时间窗: up to 3 weeks
Inflammatory responses (Based on scores): 0 = No visible reaction + = Slight, confluent, or patchy erythema 1 = Mild erythema (pink) 2 = Moderate erythema (definite redness) 3 = Strong erythema (very intense redness)
Evaluation of superficial effects
时间窗: up to 3 weeks
Superficial effects: g = Glazing y = Peeling c = Scab, dried film of serous exudate of vesicular or bulla reaction d = Hyperpigmentation (reddish brown discoloration of test site) h = Hypopigmentation (loss of visible pigmentation at test site) f = Fissuring grooves in the superficial layers of the skin
次要结局
- Adverse event collection as a measure of safety and tolerability(up to 3 weeks)