Evaluation of Anti-inflammatories in the Reduction of Bite Reactions
Evaluation of Anti-inflammatories in the Reduction of Bite Reactions
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.
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