Evaluation of Anti-inflammatories in the Reduction of Bite Reactions

This study is currently recruiting participants.
Verified March 2013 by London School of Hygiene and Tropical Medicine
Sponsor:
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01452997
First received: October 12, 2011
Last updated: March 19, 2013
Last verified: March 2013

October 12, 2011
March 19, 2013
November 2012
April 2013   (final data collection date for primary outcome measure)
size of wheal, flare in mm [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01452997 on ClinicalTrials.gov Archive Site
Subjective pain and itching [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
Subjective record of pain and itching recorded on a visual scale
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Mosquito Bite
  • Drug: NSAI treatment
    Ibuprofen 5% gel
    Other Name: Fenbid gel
  • Drug: Steroid treatment
    Steroid intervention with 0.05% w/w clobetasone butyrate.
  • Active Comparator: Ibuprofen Gel
    Ibuprofen 5% gel
    Intervention: Drug: NSAI treatment
  • Placebo Comparator: Ibuprofen placebo
    K-Y jelly
    Intervention: Drug: NSAI treatment
  • Active Comparator: Eumovate
    0.05% w/w clobetasone butyrate
    Intervention: Drug: Steroid treatment
  • Placebo Comparator: Cream Placebo
    Aqueous Cream B.P.
    Intervention: Drug: Steroid treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
June 2013
April 2013   (final data collection date for primary outcome measure)

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

Both
18 Years to 65 Years
Yes
Not Provided
United Kingdom
 
NCT01452997
QA351
No
London School of Hygiene and Tropical Medicine
London School of Hygiene and Tropical Medicine
Not Provided
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
London School of Hygiene and Tropical Medicine
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP