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Study of a Device to Relieve Mosquito Bite Itching.

Primary Purpose

Mosquito Bites

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

ZapperClick

About this trial

This is an interventional treatment trial for Mosquito Bites focused on measuring mosquito bites, itching

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

One lab-induced mosquito bite on the non-dominant forearm
Familiarity with an immediate mosquito bite reaction.
History of immediately responding to mosquito bites with itching.
Willing and able to refrain from consuming anti-histamines, corticosteroids, or Non-Steroid Anti-Inflammatory Drugs (NSAID,) for a time period of 4 half lives of the drug prior to the beginning of the study, and continuing throughout the course of the study.
Willing to abstain from the use of insect repellant and/or any treatment other than the test device for the relief of mosquito bite symptoms until after the study.
Primary written and spoken language is English.

Exclusion Criteria:

No history of prior affliction with mosquito bites.
History of lack of reaction to mosquito and/or other insect bites that includes itching.
History of hypersensitivity to the bites or stings of mosquitoes, bees or wasps.
Presence of mosquito bites or other types of insect bite/stings on any location on the body.
Current use of steroids.
Use of insect repellants during the week prior to study start.
Use of topical agents on the arm during the week prior to study start.
Pacemaker, ICD or other implantable heart device.
Therapeutic use of any type of electrical stimulation.
Epilepsy.
Diabetes.
Presence of neurological disorder.
Prior surgery to the forearm area.
Infection or wound in the forearm area.
Any skin or other disease or illness that can cause or influence skin itching, such as Psoriasis.
Developmental disability or cognitive impairment that impacts the ability to read and/or to understand the content of the informed consent form or the device labeling and/or impacts the ability to read and/or to understand and/or to complete the study case report forms.
Significant psychological disorder(s) for which treatment has become necessary, including anxiety and depression; psychiatric hospitalization.
Pregnancy or lactation.
Involvement in litigation and/or receiving disability benefits related to any kind of disability, injury, or other medical problem.
Participation in research over the preceding 90 days.

Sites / Locations

Department of Infectious & Tropical Diseases, London School of Hygiene & Tropical Medicine,

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Change in degree of itching rating on a 0-100 VAS.

Secondary Outcome Measures

Changes in 0-100 VAS itching ratings, and changes in total area of mosquito bite erythema, across the 24-hour evaluation period.

Full Information

NCT ID

NCT00822575

First Posted

January 13, 2009

Last Updated

January 13, 2009

Sponsor

Ecobrands, Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00822575

Brief Title

Study of a Device to Relieve Mosquito Bite Itching.

Official Title

Relief From Itching of Mosquito Bites Clinical Study Protocol.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Ecobrands, Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine whether over-the-counter (OTC) use of the ZapperClick device employing the piezo-electricity principle is effective in reducing itching associated with mosquito bites.

Detailed Description

The ZapperClick is a therapeutic device that employs the piezo-electricity principle to soothe itching and ease the swelling from mosquito and horsefly bites as well as jellyfish and nettle stings. It accomplishes this by discharging 13KV at 0.7mA for 10 microseconds over the area of the bite or sting each time it is activated. In this clinical study, only the indication of reducing itching from mosquito bites will be evaluated. The theory behind the device's effectiveness is that multiple high voltage, low current electrical discharges over a bug bite or sting generates warmth over the immediate area of the bite or sting which inhibits the histamine release, thus relieving the symptoms of itching and swelling arising from the bite or sting. The device is a quick, simple and painless means of reducing the annoying symptoms of mosquito bites.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mosquito Bites

Keywords

mosquito bites, itching

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Sham Comparator

Intervention Type

Device

Intervention Name(s)

ZapperClick

Intervention Description

Primary Outcome Measure Information:

Title

Change in degree of itching rating on a 0-100 VAS.

Time Frame

10 minutes

Secondary Outcome Measure Information:

Title

Changes in 0-100 VAS itching ratings, and changes in total area of mosquito bite erythema, across the 24-hour evaluation period.

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: One lab-induced mosquito bite on the non-dominant forearm Familiarity with an immediate mosquito bite reaction. History of immediately responding to mosquito bites with itching. Willing and able to refrain from consuming anti-histamines, corticosteroids, or Non-Steroid Anti-Inflammatory Drugs (NSAID,) for a time period of 4 half lives of the drug prior to the beginning of the study, and continuing throughout the course of the study. Willing to abstain from the use of insect repellant and/or any treatment other than the test device for the relief of mosquito bite symptoms until after the study. Primary written and spoken language is English. Exclusion Criteria: No history of prior affliction with mosquito bites. History of lack of reaction to mosquito and/or other insect bites that includes itching. History of hypersensitivity to the bites or stings of mosquitoes, bees or wasps. Presence of mosquito bites or other types of insect bite/stings on any location on the body. Current use of steroids. Use of insect repellants during the week prior to study start. Use of topical agents on the arm during the week prior to study start. Pacemaker, ICD or other implantable heart device. Therapeutic use of any type of electrical stimulation. Epilepsy. Diabetes. Presence of neurological disorder. Prior surgery to the forearm area. Infection or wound in the forearm area. Any skin or other disease or illness that can cause or influence skin itching, such as Psoriasis. Developmental disability or cognitive impairment that impacts the ability to read and/or to understand the content of the informed consent form or the device labeling and/or impacts the ability to read and/or to understand and/or to complete the study case report forms. Significant psychological disorder(s) for which treatment has become necessary, including anxiety and depression; psychiatric hospitalization. Pregnancy or lactation. Involvement in litigation and/or receiving disability benefits related to any kind of disability, injury, or other medical problem. Participation in research over the preceding 90 days.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nigel Hill, Ph.D.

Organizational Affiliation

London School of Hygiene and Tropical Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Infectious & Tropical Diseases, London School of Hygiene & Tropical Medicine,

City

London

ZIP/Postal Code

WC 1E 7HT

Country

United Kingdom

12. IPD Sharing Statement

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Study of a Device to Relieve Mosquito Bite Itching.

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