NCT01452997已完成4 期
Evaluation of Topical Ibuprofen and Steroid in the Reduction of Local Reactions and Symptoms From an Aedes Aegypti Mosquito Bite
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- size of wheal, flare in mm
研究概览
简要总结
The purpose of this study is to evaluate two separate antiinflammatory products for the relief of symptoms through suppression of the immunological and inflammatory response following a mosquito bite. The investigators have selected ibuprofen gel as a NSAI formulation and 0.05% Clobetasone butyrate as a steroid cream with their appropriate physical matched placebo products.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 65 years of age (inclusive). Caucasian (white or pale skin) Good health as determined by medical history and physical examination Females of child bearing potential must confirm they are not pregnant at the study start and agree not to become pregnant throughout the duration of the study.
- •History of the following triad of symptoms following a previous mosquito bite: weal, flare, and pruritus as immediate reaction to mosquito bites at least once in the past (= mosquito bite sensitive stages III or IV).
- •Willingness to attend for all study procedures at designated intervals. Willingness to provide full consent to the study
排除标准
- •Abnormalities of the skin on the forearms (including sunburn) that might interfere with the study results, as determined by the investigator/clinician during physical inspection.
- •History of clinically significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, metabolic, or other disease deemed clinically significant by investigator / clinician Use of prohibited therapies (including cosmetics on either forearm) as specified in Section 6.3.3 of the Clinical Trial Protocol (use of systemic or local antihistamines, steroids, or NSAIDs during or within 2 weeks prior to planned date of first study procedure); use of any medication considered to have an influence on the outcome of the study.
- •Any acute illness within the 7 days prior to planned date of first study procedure which might interfere with the study results (as determined by the investigator/clinician from medical history).
- •History of malignancy within 5 years of the planned date of the first study procedure Neurological or psychiatric disease, or drug or alcohol abuse which would interfere with the subject's completion of the protocol assignments.
- •Participated in research involving an investigational drug within 3 months of the planned date of first study procedure.
- •History of known anaphylactic hypersensitivity to mosquitoes bites, bee or wasp stings.
- •History of allergic reaction to any of the topical agents used in the study or any of their components.
- •History of allergy to latex or other rubber material Women who are pregnant or breastfeeding
研究组 & 干预措施
Ibuprofen Gel
Active Comparator
Ibuprofen 5% gel
干预措施: NSAI treatment (Drug)
Ibuprofen placebo
Placebo Comparator
K-Y jelly
干预措施: NSAI treatment (Drug)
Eumovate
Active Comparator
0.05% w/w clobetasone butyrate
干预措施: Steroid treatment (Drug)
Cream Placebo
Placebo Comparator
Aqueous Cream B.P.
干预措施: Steroid treatment (Drug)
结局指标
主要结局
size of wheal, flare in mm
时间窗: 90 minutes
The statistical difference between active and placebo agent on bite reaction measured as size of wheal, flare in mm and itching measured on a visual scale recorded by the subject.ct.
次要结局
- Subjective pain and itching(90 minutes)
研究者
研究点 (1)
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