Study of a Device to Relieve Mosquito Bite Itching.

NCT00822575 | Completed

• 1 other identifier: ZC-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Mosquito Bites

Keywords

mosquito bites; itching

Outcome Measures

Primary Outcomes (1)

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

  10 minutes

Secondary Outcomes (1)

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

  24 hours

Study Arms (2)

A

ACTIVE COMPARATOR

Device: ZapperClick

B

SHAM COMPARATOR

Device: ZapperClick

Interventions

ZapperClick DEVICE

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.

A; B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ecobrands, Ltd.: lead

Study Sites (1)

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

London, WC 1E 7HT, United Kingdom

Location

MeSH Terms

Conditions

Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nigel Hill, Ph.D.

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 14, 2009
• Study Start: April 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: January 14, 2009

Record last verified: 2009-01

Locations

GB (1)