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Evaluation of Anti-inflammatories in the Reduction of Bite Reactions

Primary Purpose

Mosquito Bite

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
NSAI treatment
Steroid treatment
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mosquito Bite focused on measuring mosquito, allergy, bite, ant-inflammatory, Aedes aegypti mosquito bite

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • London School of Hygiene and Tropical Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Ibuprofen Gel

Ibuprofen placebo

Eumovate

Cream Placebo

Arm Description

Ibuprofen 5% gel

K-Y jelly

0.05% w/w clobetasone butyrate

Aqueous Cream B.P.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Subjective pain and itching
Subjective record of pain and itching recorded on a visual scale

Full Information

First Posted
October 12, 2011
Last Updated
March 30, 2015
Sponsor
London School of Hygiene and Tropical Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01452997
Brief Title
Evaluation of Anti-inflammatories in the Reduction of Bite Reactions
Official Title
Evaluation of Topical Ibuprofen and Steroid in the Reduction of Local Reactions and Symptoms From an Aedes Aegypti Mosquito Bite
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London School of Hygiene and Tropical Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mosquito Bite
Keywords
mosquito, allergy, bite, ant-inflammatory, Aedes aegypti mosquito bite

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ibuprofen Gel
Arm Type
Active Comparator
Arm Description
Ibuprofen 5% gel
Arm Title
Ibuprofen placebo
Arm Type
Placebo Comparator
Arm Description
K-Y jelly
Arm Title
Eumovate
Arm Type
Active Comparator
Arm Description
0.05% w/w clobetasone butyrate
Arm Title
Cream Placebo
Arm Type
Placebo Comparator
Arm Description
Aqueous Cream B.P.
Intervention Type
Drug
Intervention Name(s)
NSAI treatment
Other Intervention Name(s)
Fenbid gel
Intervention Description
Ibuprofen 5% gel
Intervention Type
Drug
Intervention Name(s)
Steroid treatment
Intervention Description
Steroid intervention with 0.05% w/w clobetasone butyrate.
Primary Outcome Measure Information:
Title
size of wheal, flare in mm
Description
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.
Time Frame
90 minutes
Secondary Outcome Measure Information:
Title
Subjective pain and itching
Description
Subjective record of pain and itching recorded on a visual scale
Time Frame
90 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Behrens, MD FRCP
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Logan, PhD
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Study Director
Facility Information:
Facility Name
London School of Hygiene and Tropical Medicine
City
London
ZIP/Postal Code
WC1E 7HT
Country
United Kingdom

12. IPD Sharing Statement

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Evaluation of Anti-inflammatories in the Reduction of Bite Reactions

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