Evaluation of Anti-inflammatories in the Reduction of Bite Reactions

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

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.

Study Overview

• Status: Completed
• Conditions: Mosquito Bite
• Intervention / Treatment: Drug: NSAI treatment; Drug: Steroid treatment

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, WC1E 7HT
    • London School of Hygiene and Tropical Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: London School of Hygiene and Tropical Medicine
• Investigators: Principal Investigator: Ron Behrens, MD FRCP, London School of Hygiene and Tropical Medicine; Study Director: James Logan, PhD, London School of Hygiene and Tropical Medicine

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: October 12, 2011
• First Submitted That Met QC Criteria: October 14, 2011
• First Posted (Estimate): October 17, 2011

Study Record Updates

• Last Update Posted (Estimate): March 31, 2015
• Last Update Submitted That Met QC Criteria: March 30, 2015
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: allergy; mosquito; bite; ant-inflammatory; Aedes aegypti mosquito bite
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Wounds and Injuries; Poisoning; Bites and Stings
• Other Study ID Numbers: QA351