Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Evaluation of Anti-inflammatories in the Reduction of Bite Reactions

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

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.

Condition Intervention Phase
Mosquito Bite
Drug: NSAI treatment
Drug: Steroid treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Topical Ibuprofen and Steroid in the Reduction of Local Reactions and Symptoms From an Aedes Aegypti Mosquito Bite

Resource links provided by NLM:

Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • Subjective pain and itching [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
    Subjective record of pain and itching recorded on a visual scale

Estimated Enrollment: 40
Study Start Date: November 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ibuprofen Gel
Ibuprofen 5% gel
Drug: NSAI treatment
Ibuprofen 5% gel
Other Name: Fenbid gel
Placebo Comparator: Ibuprofen placebo
K-Y jelly
Drug: NSAI treatment
Ibuprofen 5% gel
Other Name: Fenbid gel
Active Comparator: Eumovate
0.05% w/w clobetasone butyrate
Drug: Steroid treatment
Steroid intervention with 0.05% w/w clobetasone butyrate.
Placebo Comparator: Cream Placebo
Aqueous Cream B.P.
Drug: Steroid treatment
Steroid intervention with 0.05% w/w clobetasone butyrate.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01452997

United Kingdom
London School of Hygiene and Tropical Medicine Recruiting
London, United Kingdom, WC1E 7HT
Contact: Ron Behrens, MD FRCP   
Contact: James Logan, PhD   
Principal Investigator: ROn Behrens, MD         
Sub-Investigator: Jame Logan, PhD         
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
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
  More Information

No publications provided

Responsible Party: London School of Hygiene and Tropical Medicine Identifier: NCT01452997     History of Changes
Other Study ID Numbers: QA351
Study First Received: October 12, 2011
Last Updated: March 19, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by London School of Hygiene and Tropical Medicine:
Aedes aegypti mosquito bite

Additional relevant MeSH terms:
Clobetasone butyrate
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on February 26, 2015