Insect BitesPhase 3NCT00825214
Evaluation of Zapperclick Device for Relief From Mosquito Bites
A Phase 3 study testing Zapperclick and Inactivated zapperclick device in people with Insect Bites and Stings, run by London School of Hygiene and Tropical Medicine at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Insect Bites, Stings
- What is being tested?
- Zapperclick and Inactivated zapperclick device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2008to Feb 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- known rection to mosquito bites
- willing to attend clinic for 2 hours during measurements
- informed written consent
Who cannot join
- hypersensitivity to bites or stings
- atopic allergy
- pacemaker
- pregnant / breast feeding
- use of other medication including pain killers
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
London School of Hygiene & Tropical Medicine
London, WC1E 7HT
About this study
Official title: Evaluation of a Piezoelectric Device (Zapperclick) for Relief From Mosquito Bites
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.
- Conditions
- Insect Bites, Stings
- Being tested
- Zapperclick, Inactivated zapperclick device
- Medical subject headings
- Insect Bites and Stings, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZapperclickDevice
Device deliveres small piezoelectrical discharge to bite site (forearm)
Inactivated zapperclick deviceDevice
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Use of zapperclick on mosquito bite Receives: Device: Zapperclick |
| 2 | Placebo comparator | use of inactivated zapperclick on mosquito bite Receives: Device: Inactivated zapperclick device |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in itching
Measured: 24 hours
Secondary outcomes (1)
reduction in erythema / oedema
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startMar 2008
- Primary completionNov 2008
- Study completionFeb 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insect BitesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825214
- Sponsor's protocol ID
- LSHTM/HILL/08/01
- Status last verified
- Jan 2009
- First submitted
- 16 Jan 2009
- Last updated
- 19 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Piezoelectric Device (Zapperclick) for Relief From Mosquito Bites
- ClinicalTrials.gov ID
- NCT00825214
- Acronym / sponsor ID
- LSHTM/HILL/08/01
- Conditions
- Insect Bites, Stings
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Feb 2009 (estimated)
- First posted
- 19 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: ZapperclickUse of zapperclick on mosquito bite |
| 2 | Placebo comparator | Device: Inactivated zapperclick deviceuse of inactivated zapperclick on mosquito bite |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- known rection to mosquito bites
- willing to attend clinic for 2 hours during measurements
- informed written consent
Key exclusion criteria (5 listed)
- hypersensitivity to bites or stings
- atopic allergy
- pacemaker
- pregnant / breast feeding
- use of other medication including pain killers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZapperclickDevice deliveres small piezoelectrical discharge to bite site (forearm) | Device | 1 |
| Inactivated zapperclick deviceplacebo | Device | 2 |
Primary outcome
reduction in itching
Time frame: 24 hours
1 secondary outcome
reduction in erythema / oedema
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zapperclick and Inactivated zapperclick device in people with Insect Bites and Stings, run by London School of Hygiene and Tropical Medicine at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in itching (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2009.