Status:
COMPLETED
Study of a Device to Relieve Mosquito Bite Itching.
Lead Sponsor:
Ecobrands, Ltd.
Conditions:
Mosquito Bites
Eligibility:
All Genders
18-65 years
Phase:
NA
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 mosqui...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00822575
Start Date
April 1 2008
End Date
June 1 2008
Last Update
January 14 2009
Active Locations (1)
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1
Department of Infectious & Tropical Diseases, London School of Hygiene & Tropical Medicine,
London, United Kingdom, WC 1E 7HT