Evaluation of Anti-inflammatories in the Reduction of Bite Reactions (NCT01452997) | Clinical Trial Compass
CompletedPhase 4
Evaluation of Anti-inflammatories in the Reduction of Bite Reactions
United Kingdom40 participantsStarted 2012-11
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 w…
What they're measuring
1
size of wheal, flare in mm
Timeframe: 90 minutes
Trial details
NCT IDNCT01452997
SponsorLondon School of Hygiene and Tropical Medicine