A 21 Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of PBI-100 Topical Cream in Healthy Participants Using a Cumulative Irritant Patch Test Design
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Irritation Potential
研究概览
简要总结
This is an open-label, single-arm, randomized, evaluator-blinded repeat insult patch testing (RIPT) study wherein test product is applied under an occlusive dressing to the upper back or arm continuously and repeatedly to the same site for a period of 21 days.
详细描述
This is an open-label, single-arm, randomized, evaluator-blinded repeat insult patch testing (RIPT) study wherein test product is applied under an occlusive dressing to the upper back or arm continuously and repeatedly to the same site for a period of 21 days. Three concentrations of PBI-100 Topical Cream and vehicle (placebo cream) will be applied to the skin of each subject. In addition, one site will be treated with a positive control and another site will be treated with a plain cotton cloth patch and will serve as a negative control.
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
- None
盲法说明
The participant and evaluator are blinded to the identity of the test product (3 strengths of PBI-100), vehicle, negative control and positive control placed on each subject's forearm, upper arm or back
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male and female volunteers between the ages of 18 and 70 years with Fitzpatrick types I, II, or III.
- •Must be willing to follow the study requirements and voluntarily give their informed consent.
- •Subjects must be able to read and follow study instructions in English.
- •Generally in good health as determined by the investigator, based on medical history interview.
- •Evidence of a personally signed and dated Informed Consent indicating that the subject has been informed of and understood all pertinent aspects of the trial.
排除标准
- •Scars, moles, or other blemishes over the forearm, upper arm, or back that interfere with the study.
- •Sunburn within the last three weeks or use of tanning beds.
- •History of allergy or hypersensitivity to skin care or consumer products including fragrances, cosmetics, toiletries, or any kind of tape.
- •History of chronic or recurrent dermatological diseases, e.g., psoriasis, atopic eczema, chronic urticaria.
- •Subjects receiving systemic or topical drugs which can interfere with the development of an inflammatory response, e.g., steroids, immunosuppressive agents, or retinoids.
- •History of any significant systemic diseases e.g., cardiac, pulmonary, renal, hepatic, etc. that would impact subject's ability to complete the study.
- •Pregnancy or mothers who are breastfeeding or planning a pregnancy.
- •Other conditions considered by the Investigator as sound reasons for disqualification from enrollment into the study.
研究组 & 干预措施
Cumulative Irritation Test
Participants will receive topical applications of three concentrations of PBI-100 Topical Cream, one application of vehicle, one application of sodium lauryl sulfate as a positive control and one application of a plain patch as a negative control daily (excluding weekends) for 21 days or 15 applications.
干预措施: PBI-100 Topical Cream (Drug)
Cumulative Irritation Test
Participants will receive topical applications of three concentrations of PBI-100 Topical Cream, one application of vehicle, one application of sodium lauryl sulfate as a positive control and one application of a plain patch as a negative control daily (excluding weekends) for 21 days or 15 applications.
干预措施: Positive Control - Sodium laurel sulfate (SLS) (Drug)
Cumulative Irritation Test
Participants will receive topical applications of three concentrations of PBI-100 Topical Cream, one application of vehicle, one application of sodium lauryl sulfate as a positive control and one application of a plain patch as a negative control daily (excluding weekends) for 21 days or 15 applications.
干预措施: PBI-100 Topical Cream, Vehicle (Other)
Cumulative Irritation Test
Participants will receive topical applications of three concentrations of PBI-100 Topical Cream, one application of vehicle, one application of sodium lauryl sulfate as a positive control and one application of a plain patch as a negative control daily (excluding weekends) for 21 days or 15 applications.
干预措施: Negative Control (Other)
结局指标
主要结局
Irritation Potential
时间窗: 21 days
Irritation potential based on the Cumulative Irritation Index (CII)
次要结局
未报告次要终点