Comparative Study of Two Forms of Topical Dexchlorpheniramine Maleate (Cream Versus Gel) for Insect Bites
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Pruritus Intensity at Insect Bite Site, Evaluated With a 10 Point Visual Analogic Scale (VAS)
研究概览
简要总结
Insect bite related symptoms (pruritus and papules) are caused by the release of histamine by mast cells in the skin. Topical anti-histaminics can be used to promote relief of these symptoms. Dexchlorpheniramine maleate 1% cream is a topical anti-histaminic formulation approved by ANVISA in Brazil for the relief of skin irritation and allergies, including the ones caused by insect bites. The aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% gel) with the standard preparation (1% cream) for the relief of insect bite 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
- •Presence of papules resulting from insect bites within the last 72 hours;
- •Presence of symmetric lesions to compare one side to the other;
- •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;
- •Use of topical or systemic anti-inflammatory, anti-histaminics or immunosuppressive drugs within the last 48 hours prior to the study;
- •History of atopy or allergic diseases;
- •History of allergy of 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% Cream
干预措施: Dexchlorpheniramine 1% Cream (Drug)
Dexchlorpheniramine 1% Gel
干预措施: Dexchlorpheniramine 1% Gel (Drug)
结局指标
主要结局
Pruritus Intensity at Insect Bite Site, 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 Papule Formation, Performed by the Investigator Using a 4-point Scale for Each One of the Parameters (Absent, Mild, Moderate, Intense). This Evaluation Constitutes the Insect Bite Score.(7 days)