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Completed

NCT Number: NCT01452997

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

London School of Hygiene and Tropical Medicine

London, WC1E 7HT, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NSAI treatment

Drug

Ibuprofen 5% gel

Other names: Fenbid gel

Steroid treatment

Drug

Steroid intervention with 0.05% w/w clobetasone butyrate.

Primary outcomes

  1. size of wheal, flare in mm

    Time frame: 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.

Secondary outcomes

  1. Subjective pain and itching

    Time frame: 90 minutes

    Subjective record of pain and itching recorded on a visual scale

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 17, 2011
Registry last updated
Mar 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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