Evaluation of Anti-inflammatories in the Reduction of Bite Reactions
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Purpose
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 |
- 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.
- 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.
|
Eligibility| 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| United Kingdom | |
| London School of Hygiene and Tropical Medicine | Recruiting |
| London, United Kingdom, WC1E 7HT | |
| Contact: Ron Behrens, MD FRCP ron.behrens@lshtm.ac.uk | |
| Contact: James Logan, PhD james.logan@lshtm.ac.uk | |
| Principal Investigator: ROn Behrens, MD | |
| Sub-Investigator: Jame Logan, PhD | |
| 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 |
| ClinicalTrials.gov 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:
|
mosquito allergy bite ant-inflammatory Aedes aegypti mosquito bite |
Additional relevant MeSH terms:
|
Clobetasone butyrate Anti-Inflammatory Agents Ibuprofen Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 16, 2013