Non-inferiority, Monocentric Comparative Open Study of Two Topical Pharmaceutical Preparations (Cream and Lotion) of Dexchlorpheniramine Maleate in the Evaluation of Safety and Efficacy for the Relief of Sunburn Related Symptoms
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pruritus intensity evaluated with a 10-point Visual Analogic Scale (VAS)
研究概览
简要总结
Topical antihistamines can be used to promote relief of sunburn related symptoms (erythema, itch and burning sensations). Dexchlorpheniramine maleate 1% cream is a topical antihistamine formulation approved by ANVISA in Brazil for the relief of skin irritation and pruritus, including the ones caused by sunburn. The aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% lotion) with the standard preparation (1% cream) for the relief of sunburn related symptoms and to demonstrate the safety of both preparations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signs of solar erythema of mild to moderate intensity resulting from voluntary exposure to sun within the last 72 hours
- •Presence of lesions with some degree of symmetry to allow comparison between both pharmaceutical formulations
- •Compliance of the subject to the treatment protocol
- •Agreement with the terms of the informed consent by the participants or their legal guardians when younger than 18 years old
排除标准
- •Pregnancy or risk of pregnancy
- •Lactation
- •Signs of solar erythema of severe intensity
- •Use of topical or systemic anti-inflammatory, antihistamine or immunosuppressive drugs within the last 48 hours prior to the study
- •History of atopy or allergic diseases
- •History of allergy to any component of the formulations
- •Other conditions considered by the investigator as reasonable for non-eligibility
研究组 & 干预措施
Dexchlorpheniramine 1% lotion
干预措施: Dexchlorpheniramine 1% lotion (Drug)
Dexchlorpheniramine 1% cream
干预措施: Dexchlorpheniramine 1% cream (Drug)
结局指标
主要结局
Pruritus intensity evaluated with a 10-point Visual Analogic Scale (VAS)
时间窗: 7 days
次要结局
- Composite clinical evaluation of erythema, pruritus and burning sensation performed by the investigator using a 4-point scale for each one of the variables (absent, mild, moderate, intense).(7 days)