Phase I Clinical Trial to Investigate the Cumulative Skin Irritation of PAC-14028 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Irritation Score (5-point scale, 0-4)
研究概览
简要总结
The purpose of this study is to determine the cumulative irritation potential of the products listed by the Sponsor.
详细描述
Healthy, adult volunteers of either sex will be patched daily on his/her arm with multiple strengths of PAC-14028 cream, non-active comparator and an active comparator over the course of 21 consecutive days. Twenty-four hours after each application, the Finn-chamber patches will be removed and the site evaluated using a five-point scale for irritation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers of either sex, at least 20 years to 59 Years.
- •Females must be of non-childbearing potential (i.e., post-menopausal or surgically sterile). All females must submit to a urine pregnancy test and have a negative result at Day 1 and at the final study visit.
- •Subjects may be of any skin type or race providing their degree of skin pigmentation does not interfere with readings of skin reactions.
- •Who voluntarily decides study participation after receiving detailed explanation about the study and fully understanding it and who provides written consent for compliance with study requirement including proper contraception.
排除标准
- •Atopic dermatitis/eczema, psoriasis will be excluded. Any skin disease that would in any way confound interpretation of the study results.
- •Asthma and chronic bronchitis will be excluded.
- •Inability to evaluate the skin in and around the potential patch test sites on the arm due to erythema, eschar, excoriation, tattoos, scars, unevenness in skin tones, or other skin damage or abnormality.
- •A history of sensitivity to any component of any of the formulations and the Finn chamber.
- •Used systemic or topical corticosteroids or other immunosuppressive medications within 1 weeks of the Day 1 visit.
- •Used nonsteroidal anti-inflammatory medications within 2 weeks of the Day 1 visit.
- •Received immunizations within 2 weeks of the Day 1 visit.
- •Any major illness within 4 weeks of the Day 1 visit.
- •Female who is pregnant, trying to become pregnant, or breast feeding
- •Use of chronic medications (such as antihistamines, corticosteroids, analgesics and anti-inflammatories) for one week before and during the study.
- •Currently using any medication that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk.
研究组 & 干预措施
PAC14028-Vehicle
PAC-14028 Cream Vehicle
干预措施: PAC14028-Vehicle (Other)
PAC14028-0.1
PAC-14028 Cream 0.1%
干预措施: PAC14028-0.1 (Drug)
PAC14028-0.3
PAC-14028 Cream 0.3%
干预措施: PAC14028-0.3 (Drug)
PAC14028-1.0
PAC-14028 Cream 1%
干预措施: PAC14028-1.0 (Drug)
Placebo
Saline
干预措施: Saline (Other)
Positive control
Sodium Lauryl Sulfate, 0.5%
干预措施: Positive (Other)
结局指标
主要结局
Irritation Score (5-point scale, 0-4)
时间窗: Daily for 21 days
次要结局
未报告次要终点