Study of a Device to Relieve Mosquito Bite Itching.

Relief From Itching of Mosquito Bites Clinical Study Protocol.

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.

Study Overview

• Status: Completed
• Conditions: Mosquito Bites
• Intervention / Treatment: Device: ZapperClick

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, WC 1E 7HT
    • Department of Infectious & Tropical Diseases, London School of Hygiene & Tropical Medicine,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A	Device: ZapperClick; 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.
Sham Comparator: B	Device: ZapperClick; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in degree of itching rating on a 0-100 VAS.	10 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ecobrands, Ltd.
• Investigators: Principal Investigator: Nigel Hill, Ph.D., London School of Hygiene and Tropical Medicine

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: January 13, 2009
• First Submitted That Met QC Criteria: January 13, 2009
• First Posted (Estimate): January 14, 2009

Study Record Updates

• Last Update Posted (Estimate): January 14, 2009
• Last Update Submitted That Met QC Criteria: January 13, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Keywords: itching; mosquito bites
• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus
• Other Study ID Numbers: ZC-001