Evaluation of Zapperclick Device for Relief From Mosquito... | NCT00825214

Studies
Evaluation of Zapperclick Device for Relief From Mosquito Bites

NCT00825214

Sponsor

London School of Hygiene and Tropical Medicine

Status

Unknown status

Last Update Posted

Jan 19, 2009Estimated

Enrollment

120Estimated

Phase

Phase 3

Conditions

Insect Bites
Stings

Interventions

Zapperclick
Inactivated zapperclick device

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Nov 2008Actual

Completion Date

Feb 2009Estimated

First Submitted Date

Jan 16, 2009

First Submission Date that Met QC Criteria

Jan 16, 2009

First Posted Date

Jan 19, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2009

Last Update Posted Date

Jan 19, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Use of zapperclick on mosquito bite	Device: Zapperclick
2	Placebo Comparator	use of inactivated zapperclick on mosquito bite	Device: Inactivated zapperclick device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zapperclick	Device	Device deliveres small piezoelectrical discharge to bite site (forearm)	1

Measure	Description	Time Frame
reduction in itching		24 hours

Measure	Description	Time Frame
reduction in erythema / oedema		24 hours

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
London School of Hygiene & Tropical Medicine		London		WC1E 7HT	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D007299	Insect Bites and Stings
D001733	Bites and Stings

Ancestor Terms

ID	Term
D011041	Poisoning
D064419	Chemically-Induced Disorders
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided