A Cumulative Skin Irritation Study Investigating the Skin Irritancy Potential of MFC51123 Diclofenac-Menthol Gel
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Treatment mean cumulative irritation score
研究概览
简要总结
This research study is being conducted to investigate the skin irritancy potential of a new medication which contains two active ingredients (diclofenac and menthol) together in a gel formulation and is being developed to treat mild to moderate pain and inflammation, such as acute sport injuries, sprains and strains.
详细描述
Approximately 36 healthy subject volunteers will be exposed to seven test products (study treatment gel and six control products) simultaneously for 21 consecutive days. The seven test products will be applied using a 7-channel patch assembly that will be affixed to the infrascapular areas of the back of each subject for approximately 24 hours daily.
The subject will return to the clinic to undergo a skin irritation assessment at approximately 24 hours after the time the patch assembly was initially affixed.
During the visits, doctors or trained staff members will examine the signs of irritation (if any) of the skin where the test products are applied. The skin irritation assessment will primarily characterize the test products individually in terms of symptomatology using a 7-point categorical scale ranging from 1 (glazing and/or wrinkling) to 7 (erosion and/or vesiculation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (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
- •Male/female volunteer ≥18 years
- •No systemic/dermatologic disorder
排除标准
- •Visible skin disease at the site of application that might interfere with skin assessments
- •Allergy or hypersensitivity to NSAIDs or menthol or any of the excipients in the test product
- •History of physical or psychiatric illness, or medical disorder
- •Recent history of alcohol or drug abuse
- •Pregnant or lactating females
研究组 & 干预措施
Menthol Gel
3% menthol
干预措施: 3% Menthol (Drug)
Diclofenac Sodium/Menthol Gel
1% diclofenac sodium + 3% menthol
干预措施: 1% Diclofenac Sodium (Drug)
Diclofenac Sodium/Menthol Gel
1% diclofenac sodium + 3% menthol
干预措施: 3% Menthol (Drug)
Diclofenac Gel
1% diclofenac sodium + 0.09% menthol
干预措施: 1% Diclofenac Sodium (Drug)
Diclofenac Gel
1% diclofenac sodium + 0.09% menthol
干预措施: 0.09% Menthol (Drug)
Placebo Gel
0.09% menthol
干预措施: 0.09% Menthol (Drug)
Voltaren Gel
1% diclofenac sodium
干预措施: 1% Diclofenac Sodium (Drug)
Sodium lauryl sulfate
0.2% Sodium lauryl sulfate
干预措施: 0.2% Sodium Lauryl Sulfate (Drug)
Saline
0.9% saline
干预措施: 0.9% Saline (Drug)
结局指标
主要结局
Treatment mean cumulative irritation score
时间窗: Day 21
Cumulative irritation scores will be defined daily as the sum of irritation score and grade number
Adverse event assessment
时间窗: 21 days + 5 days follow-up
Adverse events will be graded on a three-point scale: 1. Mild-easily tolerated, causing minimal discomfort and not interfering with normal everyday activities; 2. Moderate-sufficiently discomforting to interfere with normal everyday activities; 3. Severe-any event that prevents normal everyday activities
次要结局
未报告次要终点