NCT00825214

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 19, 2009

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

January 19, 2009

Status Verified

January 1, 2009

Enrollment Period

8 months

First QC Date

January 16, 2009

Last Update Submit

January 16, 2009

Conditions

Insect BitesStings

Outcome Measures

Primary Outcomes (1)

  • reduction in itching

    24 hours

Secondary Outcomes (1)

  • reduction in erythema / oedema

    24 hours

Study Arms (2)

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

ZapperclickDEVICE

Device deliveres small piezoelectrical discharge to bite site (forearm)

1
Inactivated zapperclick deviceDEVICE

placebo

2

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • known rection to mosquito bites
  • willing to attend clinic for 2 hours during measurements
  • informed written consent

You may not qualify if:

  • hypersensitivity to bites or stings
  • atopic allergy
  • pacemaker
  • pregnant / breast feeding
  • use of other medication including pain killers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London School of Hygiene & Tropical Medicine

London, WC1E 7HT, United Kingdom

Location

MeSH Terms

Conditions

Insect Bites and StingsBites and Stings

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 16, 2009

First Posted

January 19, 2009

Study Start

March 1, 2008

Primary Completion

November 1, 2008

Study Completion

February 1, 2009

Last Updated

January 19, 2009

Record last verified: 2009-01

Locations

GB(1)