Evaluation of Zapperclick Device for Relief From Mosquito Bites
Primary Purpose
Insect Bites, Stings
Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Zapperclick
Inactivated zapperclick device
Sponsored by
About this trial
This is an interventional treatment trial for Insect Bites
Eligibility Criteria
Inclusion Criteria:
- known rection to mosquito bites
- willing to attend clinic for 2 hours during measurements
- informed written consent
Exclusion Criteria:
- hypersensitivity to bites or stings
- atopic allergy
- pacemaker
- pregnant / breast feeding
- use of other medication including pain killers
Sites / Locations
- London School of Hygiene & Tropical Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Use of zapperclick on mosquito bite
use of inactivated zapperclick on mosquito bite
Outcomes
Primary Outcome Measures
reduction in itching
Secondary Outcome Measures
reduction in erythema / oedema
Full Information
NCT ID
NCT00825214
First Posted
January 16, 2009
Last Updated
January 16, 2009
Sponsor
London School of Hygiene and Tropical Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00825214
Brief Title
Evaluation of Zapperclick Device for Relief From Mosquito Bites
Official Title
Evaluation of a Piezoelectric Device (Zapperclick) for Relief From Mosquito Bites
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
February 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
London School of Hygiene and Tropical Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Mosquito bites commonly result in redness, swelling and itching. This study will determine if a device that emits a small piezo-electrical impulse can provide relief from these symptoms. Volunteers entering the study will have a mosquito bite on one forearm. Redness and irritation will be recorded periodically for 24 hours. Comparing data from subjects randomised to the treatment or a placebo device will be analysed to determine effectiveness of the product. We will also ask the subjects their view on how easy the product is to use and clarity of instructions provided.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insect Bites, Stings
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Use of zapperclick on mosquito bite
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
use of inactivated zapperclick on mosquito bite
Intervention Type
Device
Intervention Name(s)
Zapperclick
Intervention Description
Device deliveres small piezoelectrical discharge to bite site (forearm)
Intervention Type
Device
Intervention Name(s)
Inactivated zapperclick device
Intervention Description
placebo
Primary Outcome Measure Information:
Title
reduction in itching
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
reduction in erythema / oedema
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
known rection to mosquito bites
willing to attend clinic for 2 hours during measurements
informed written consent
Exclusion Criteria:
hypersensitivity to bites or stings
atopic allergy
pacemaker
pregnant / breast feeding
use of other medication including pain killers
Facility Information:
Facility Name
London School of Hygiene & Tropical Medicine
City
London
ZIP/Postal Code
WC1E 7HT
Country
United Kingdom
12. IPD Sharing Statement
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Evaluation of Zapperclick Device for Relief From Mosquito Bites
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