Evaluation of Anti-inflammatories in the Reduction of Bite Reactions

NCT01452997 | Completed Phase 4

• 1 other identifier: QA351
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Mosquito Bite

Keywords

mosquito; allergy; bite; ant-inflammatory; Aedes aegypti mosquito bite

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Subjective pain and itching

  90 minutes

Study Arms (4)

Ibuprofen Gel

ACTIVE COMPARATOR

Ibuprofen 5% gel

Drug: NSAI treatment

Ibuprofen placebo

PLACEBO COMPARATOR

K-Y jelly

Drug: NSAI treatment

Eumovate

ACTIVE COMPARATOR

0.05% w/w clobetasone butyrate

Drug: Steroid treatment

Cream Placebo

PLACEBO COMPARATOR

Aqueous Cream B.P.

Drug: Steroid treatment

Interventions

NSAI treatment DRUG

Ibuprofen 5% gel

Also known as: Fenbid gel

Ibuprofen Gel; Ibuprofen placebo

Steroid treatment DRUG

Steroid intervention with 0.05% w/w clobetasone butyrate.

Cream Placebo; Eumovate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead

Study Sites (1)

London School of Hygiene and Tropical Medicine

London, WC1E 7HT, United Kingdom

Location

MeSH Terms

Conditions

Hypersensitivity; Bites and Stings

Condition Hierarchy (Ancestors)

Immune System Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Ron Behrens, MD FRCP

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

• James Logan, PhD

  London School of Hygiene and Tropical Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2011
• First Posted: October 17, 2011
• Study Start: November 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: March 31, 2015

Record last verified: 2013-03

Locations

GB (1)