A Randomized Study to Assess the Potential for Phototoxicity 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
- 32
- 主要终点
- Skin irritation
研究概览
简要总结
The primary objective of this study was to evaluate the potential for phototoxicity of the sun care products SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 compared to that of a negative control (0.9% sodium chloride [NaCl]) after a single 24 h application of test materials followed by irradiation with ultraviolet A (UVA) and ultraviolet B (UVB).
The secondary objective of this study was to evaluate the safety of the sun care products SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 combined with UVA/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
- •Male or female subjects, aged 18 to 65 years
- •Good general health, as assessed by medical history and brief visual examination of the skin
- •Fitzpatrick skin Type I IV, determined by interview at screening
- •Willing and able to practice an acceptable measure of contraception during the study, if female of childbearing potential
- •Willing to follow study rules, which include: no sun exposure; avoidance of activities that would cause excessive sweating; and no use of lotions, creams, or oils on the back area
- •Must be willing not to change current brand of personal care products such as soaps, body washes, laundry detergent, body sprays, and body spritzes 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 (SPF 50 Y65 110,SPF 50 Y51 002, and SPF 15 V27 l 04 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 (SPF 50 Y65 110,SPF 50 Y51 002, and SPF 15 V27 l 04 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 (SPF 50 Y65 110,SPF 50 Y51 002, and SPF 15 V27 l 04 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 (SPF 50 Y65 110,SPF 50 Y51 002, and SPF 15 V27 l 04 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
Skin irritation
时间窗: up to 1 week
Skin irritation was rated on a scale from 0-7 where 0 is no evidence of irritation and 7 is strong reaction spreading beyond test site
次要结局
- Number of adverse event as a measure of safety and tolerability(up to 1 week)