Pediculus CapitisNCT02854878
Treatment of Head Lice Infestation Using Novel Ultrasonic Comb
A study testing The Lucy ultrasonic comb models A and B combined with the LucyGel in people with Pediculus Capitis, run by ParaSonic Ltd. at 1 site in Israel.
Trial summary
A pilot study to evaluate safety and efficacy of the Lucy combined with LucyGel in killing head lice and their eggs. 23 participants will be enrolled in this study. The first 12 will be combed with model A and the remaining 11 will be combed with model B Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pediculus Capitis
- What is being tested?
- The Lucy ultrasonic comb models A and B combined with the LucyGel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteIsrael
- Study dates
- 28 Nov 2016to 26 Jul 2018
- Phase
- Interventional
- 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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Males and Females
- Age 6 years and older at the time of enrollment
- Must have an active head lice infestation of at least 10live head lice (found within 5 minutes of mechanic search).
- Hair must be at least 3 cm long.
- Written informed consent - by patient (if over 18 years of age), or by a parent (if patient is under 18 years of age).
- For females of childbearing potential, a statement declaring that she is not currently pregnant.
Who cannot join
- Used any chemical head lice treatment in the 7 days preceding the trial treatment
- Used antibiotics in the week preceding treatment
- Open wounds in the treatment area
- Skin irritation in the treatment area
- Individuals with skin/scalp condition at the treatment site which, in the opinion of the investigator, will interfere with treatment or evaluation
- Known allergies to any of the gel's components
- Participant that is already enrolled in another study
- Participant who can't be combed with fine Comb dense ASSY2000
Trial locations and contacts
1 site in 1 country.
About this study
A pilot study to evaluate safety and efficacy of the Lucy combined with LucyGel in killing head lice and their eggs.
23 participants will be enrolled in this study. The first 12 will be combed with model A and the remaining 11 will be combed with model B
- Conditions
- Pediculus Capitis
- Being tested
- The Lucy ultrasonic comb models A and B combined with the LucyGel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Lucy ultrasonic comb models A and B combined with the LucyGelDevice
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Not described Receives: Device: The Lucy ultrasonic comb models A and B combined with the LucyGel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events of the device and treatment
measured by AE
Measured: up to three days
Secondary outcomes (2)
Mortality of up to 70% of the mature head lice 3 hours post treatment
Measured: 3 hours post treatment
Mortality of up to 50% of the head lice eggs 14 days post treatment.
Measured: 14 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study start28 Nov 2016
- Primary completion26 Jul 2018
- Study completion26 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediculus CapitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- ParaSonic Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854878
- Sponsor's protocol ID
- CL-001
- Status last verified
- Mar 2019
- First submitted
- 26 Jul 2016
- Last updated
- 29 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Head Lice Infestation Using Novel Ultrasonic Comb
- ClinicalTrials.gov ID
- NCT02854878
- Acronym / sponsor ID
- CL-001
- Conditions
- Pediculus Capitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- ParaSonic Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Nov 2016 (actual)
- Primary completion
- 26 Jul 2018 (actual)
- Study completion
- 26 Jul 2018 (actual)
- First posted
- 4 Aug 2016 (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.
A pilot study to evaluate safety and efficacy of the Lucy combined with LucyGel in killing head lice and their eggs.
23 participants will be enrolled in this study. The first 12 will be combed with model A and the remaining 11 will be combed with model B
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Device: The Lucy ultrasonic comb models A and B combined with the LucyGel |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Males and Females
- Age 6 years and older at the time of enrollment
- Must have an active head lice infestation of at least 10live head lice (found within 5 minutes of mechanic search).
- Hair must be at least 3 cm long.
- Written informed consent - by patient (if over 18 years of age), or by a parent (if patient is under 18 years of age).
Key exclusion criteria (8 listed)
- Used any chemical head lice treatment in the 7 days preceding the trial treatment
- Used antibiotics in the week preceding treatment
- Open wounds in the treatment area
- Skin irritation in the treatment area
- Individuals with skin/scalp condition at the treatment site which, in the opinion of the investigator, will interfere with treatment or evaluation
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 |
|---|---|---|
| The Lucy ultrasonic comb models A and B combined with the LucyGel | Device | treatment |
Primary outcome
Adverse events of the device and treatment
Time frame: up to three days
measured by AE
2 secondary outcomes
Mortality of up to 70% of the mature head lice 3 hours post treatment
Time frame: 3 hours post treatment
Mortality of up to 50% of the head lice eggs 14 days post treatment.
Time frame: 14 days post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
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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 study testing The Lucy ultrasonic comb models A and B combined with the LucyGel in people with Pediculus Capitis, run by ParaSonic Ltd. at 1 site in Israel.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 29 Mar 2019. 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 Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse events of the device and treatment (time frame: up to three days). 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 29 Mar 2019.