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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00825214
Other study ID # LSHTM/HILL/08/01
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received January 16, 2009
Last updated January 16, 2009
Start date March 2008
Est. completion date February 2009

Study information

Verified date January 2009
Source London School of Hygiene and Tropical Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Mosquito bites commonly result in redness, swelling and itching. This study will determine if a device that emits a small piezo-electrical impulse can provide relief from these symptoms. Volunteers entering the study will have a mosquito bite on one forearm. Redness and irritation will be recorded periodically for 24 hours. Comparing data from subjects randomised to the treatment or a placebo device will be analysed to determine effectiveness of the product. We will also ask the subjects their view on how easy the product is to use and clarity of instructions provided.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 120
Est. completion date February 2009
Est. primary completion date November 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 16 Years to 60 Years
Eligibility Inclusion Criteria:

- known rection to mosquito bites

- willing to attend clinic for 2 hours during measurements

- informed written consent

Exclusion Criteria:

- hypersensitivity to bites or stings

- atopic allergy

- pacemaker

- pregnant / breast feeding

- use of other medication including pain killers

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Zapperclick
Device deliveres small piezoelectrical discharge to bite site (forearm)
Inactivated zapperclick device
placebo

Locations

Country Name City State
United Kingdom London School of Hygiene & Tropical Medicine London

Sponsors (1)

Lead Sponsor Collaborator
London School of Hygiene and Tropical Medicine

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary reduction in itching 24 hours No
Secondary reduction in erythema / oedema 24 hours No
See also
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Not yet recruiting NCT01233934 - Comparative Study of Two Forms of Topical Dexchlorpheniramine Maleate (Cream Versus Gel) for Insect Bites Phase 3
Terminated NCT03619746 - Point-of-Care Ultrasound Educational Initiative for Insect Bites N/A
Unknown status NCT00995397 - Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Lotion) in the Relief of Insect Bite Related Symptoms Phase 3