Safety Study to Investigate the Skin Sensitization Potential of MFC51123
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 227
- 试验地点
- 1
- 主要终点
- Skin irritation
研究概览
简要总结
This research study is being carried out to determine the possibility that a new medication causes allergic reactions. This new medication contains two active ingredients (diclofenac and menthol) together in a gel and is being developed to treat mild to moderate pain and inflammation, such as acute sport injuries, and sprains and strains. Approximately 240 participants will have the medication (gel) applied to the skin on a small area of the upper back for approximately 48-hour or 72-hour periods over the course of six weeks. Participation in this research study is voluntary, requiring participants to visit the study clinic on 17 occasions for about 45 minutes each visit. During the visits, doctors or trained staff members will examine the amount of redness, swelling, and other signs of irritation (if any) of the skin where the medication (gel) was applied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men or women participants with 18 years of age or older.
排除标准
- •Participants with a history of hypersensitivity, allergy with the use of NSAIDs or menthol or currently receiving systemic or topical NSAIDs within 3 days of visit
- •Participants having psoriasis and/or active atopic dermatitis/eczema, and skin infected.
- •Lesions, burn or wound in the application site.
研究组 & 干预措施
Diclofenac + Menthol Gel
1% diclofenac, 3% menthol
干预措施: Diclofenac + Menthol Gel (Drug)
Diclofenac Only Gel
1% diclofenac, 0.09% menthol
干预措施: Diclofenac Only Gel (Drug)
Menthol Only Gel
3% menthol
干预措施: Menthol Only Gel (Drug)
Placebo Only Gel
0.09% menthol
干预措施: Placebo Only Gel (Drug)
结局指标
主要结局
Skin irritation
时间窗: At least 23 days but not more than 30 days for induction and challenge phases combined
During the Induction Phase, the test article and three controls will be applied to adjacent treatment sites on the infrascapular area of the back for nine 48-hour patch applications. Evaluation of dermal reactions at the application sites will be conducted clinically using a visual scale that rates the degree of erythema, edema, and other signs of cutaneous irritation at nine intervals spaced approximately 48-72 hours apart. Following the Induction Phase participants will return to the clinic to begin the Challenge Phase after 12 to 14- day rest phase. The Challenge Phase will consist of one 48-hour patch application to a naive site on the opposite side of the back. Evaluations of dermal reactions at the application sites will be conducted clinically during the Challenge Phase using the same visual scale at 30 minutes, 24 hours, 48 hours, and 72 hours after removal of the challenge patch.
次要结局
- Effects on Superficial Layers of the Skin(At least 23 days but not more than 30 days for induction and challenge phases combined)
- Response notation(At least 23 days but not more than 30 days for induction and challenge phases combined)