Evaluation of Anti-inflammatories in the Reduction of Bite Reactions

Mosquito Bite Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452997
• Other study ID #: QA351
• Status: Completed
• Phase: Phase 4
• First received: October 12, 2011
• Last updated: March 30, 2015
• Start date: November 2012
• Est. completion date: April 2013

Study information

• Verified date: March 2013
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mosquito Bite

Intervention

Drug:
• NSAI treatment
Ibuprofen 5% gel
• Steroid treatment
Steroid intervention with 0.05% w/w clobetasone butyrate.

Locations

Country	Name	City	State
United Kingdom	London School of Hygiene and Tropical Medicine	London

Sponsors (1)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Subjective pain and itching	Subjective record of pain and itching recorded on a visual scale	90 minutes	No