Evaluation of Anti-inflammatories in the Reduction of Bite Reactions

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Topical Ibuprofen and Steroid in the Reduction of Local Reactions and Symptoms From an Aedes Aegypti Mosquito Bite

Conditions
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Mosquito Bite

Intervention / Treatment
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* Drug: NSAI treatment
* Drug: Steroid treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ibuprofen Gel<br>Ibuprofen 5% gel | Drug: NSAI treatment<br>* Ibuprofen 5% gel<br>* Other names: Fenbid gel;|
| Placebo Comparator: Ibuprofen placebo<br>K-Y jelly | Drug: NSAI treatment<br>* Ibuprofen 5% gel<br>* Other names: Fenbid gel;|
| Active Comparator: Eumovate<br>0.05% w/w clobetasone butyrate | Drug: Steroid treatment<br>* Steroid intervention with 0.05% w/w clobetasone butyrate.<br>|
| Placebo Comparator: Cream Placebo<br>Aqueous Cream B.P. | Drug: Steroid treatment<br>* Steroid intervention with 0.05% w/w clobetasone butyrate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| size of wheal, flare in mm | 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. | 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective pain and itching | Subjective record of pain and itching recorded on a visual scale | 90 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mosquito, allergy, bite, ant-inflammatory, Aedes aegypti mosquito bite