Evaluation of Anti-inflammatories in the Reduction of Bite Reactions

NCT ID: NCT01452997

Last Updated: 2015-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ibuprofen Gel

Ibuprofen 5% gel

Group Type: ACTIVE_COMPARATOR

NSAI treatment

Intervention Type: DRUG

Ibuprofen 5% gel

Ibuprofen placebo

K-Y jelly

Group Type: PLACEBO_COMPARATOR

NSAI treatment

Intervention Type: DRUG

Ibuprofen 5% gel

Eumovate

0.05% w/w clobetasone butyrate

Group Type: ACTIVE_COMPARATOR

Steroid treatment

Intervention Type: DRUG

Steroid intervention with 0.05% w/w clobetasone butyrate.

Cream Placebo

Aqueous Cream B.P.

Group Type: PLACEBO_COMPARATOR

Steroid treatment

Intervention Type: DRUG

Steroid intervention with 0.05% w/w clobetasone butyrate.

Interventions

NSAI treatment

Ibuprofen 5% gel

Intervention Type: DRUG

Steroid treatment

Steroid intervention with 0.05% w/w clobetasone butyrate.

Intervention Type: DRUG

Other Intervention Names

Fenbid gel

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ron Behrens, MD FRCP

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

James Logan, PhD

Role: STUDY_DIRECTOR

London School of Hygiene and Tropical Medicine

Locations

London School of Hygiene and Tropical Medicine

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

QA351

Identifier Type: -

Identifier Source: org_study_id