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Study of a Device to Relieve Mosquito Bite Itching.

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ClinicalTrials.gov Identifier: NCT00822575
Recruitment Status : Completed
First Posted : January 14, 2009
Last Update Posted : January 14, 2009
Sponsor:
Information provided by:
Ecobrands, Ltd.

Tracking Information
First Submitted Date  ICMJE January 13, 2009
First Posted Date  ICMJE January 14, 2009
Last Update Posted Date January 14, 2009
Study Start Date  ICMJE April 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2009)
Change in degree of itching rating on a 0-100 VAS. [ Time Frame: 10 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of a Device to Relieve Mosquito Bite Itching.
Official Title  ICMJE Relief From Itching of Mosquito Bites Clinical Study Protocol.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Mosquito Bites
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Active Comparator: A
    Intervention: Device: ZapperClick
  • Sham Comparator: B
    Intervention: Device: ZapperClick
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2009)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00822575
Other Study ID Numbers  ICMJE ZC-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mr. Robin Baker, EcoBrands, Ltd.
Study Sponsor  ICMJE Ecobrands, Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nigel Hill, Ph.D. London School of Hygiene and Tropical Medicine
PRS Account Ecobrands, Ltd.
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP