Pediculosis CapitisNCT01514513
Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin
A study testing Licefreee Spray and 1% permethrin creme rinse in people with Pediculosis Capitis, run by South Florida Family Health and Research Centers at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of Licefreee Spray in eradicating head lice as compared to Nix, both are available over-the-counter lice treatments. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pediculosis Capitis
- What is being tested?
- Licefreee Spray and 1% permethrin creme rinse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Must be 4 years of age or older
- Must have an active head lice infestation of at least 10 lice and viable nits
- Agree not used any other pediculicides or medicated products during the study
- Agree not to use a nit comb during the study
- Must have a single place of residence
Who cannot join
- Used any form of head lice treatment, prescription, OTC or home remedy for at least four weeks prior to their visit
- Used topical medication of any kind on the hair for a period of 48 hours prior to visit
- Individuals receiving systemic, topical drugs or medications which may interfere with the study results
- Has a history of allergy or hypersensitivity to ragweed or any ingredient in either test products
- Individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigator, will interfere with the evaluation
- Females who are pregnant or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
Lice Source Services Inc.
Plantation, Florida, 33313
About this study
Official title: A Comparative Study to Demonstrate the Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin in Head Lice Infested Individuals
The purpose of this study is to evaluate the safety and efficacy of Licefreee Spray in eradicating head lice as compared to Nix, both are available over-the-counter lice treatments.
Read the detailed description
Head lice is a worldwide problem. Many treatments for lice appear to be losing their effectiveness; therefore products are needed that safely and effectively eradicate lice.
- Conditions
- Pediculosis Capitis
- Being tested
- Licefreee Spray, 1% permethrin creme rinse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Licefreee SprayDrug
Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
1% permethrin creme rinseDrug
Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
| Study group | Role | What they receive |
|---|---|---|
| Licefreee Spray | Experimental | Not described Receives: Drug: Licefreee Spray |
| Nix Creme Rinse, 1% Permethrin | Active comparator | Not described Receives: Drug: 1% permethrin creme rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion Within Each Treatment Group of Subjects Who Have no Live Lice
No live lice 15 days following initial treatment
Measured: 15 days
Secondary outcomes (1)
Adverse Events
Number of participants with adverse events
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study startAug 2011
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pediculosis 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Florida Family Health and Research Centers
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Lidia Serrano, Principal investigator, South Florida Family Health and Research Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514513
- Sponsor's protocol ID
- LF001-0011
- Status last verified
- Dec 2014
- First submitted
- 11 Jan 2012
- Last updated
- 1 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study to Demonstrate the Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin in Head Lice Infested Individuals
- ClinicalTrials.gov ID
- NCT01514513
- Acronym / sponsor ID
- LF001-0011
- Conditions
- Pediculosis Capitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- South Florida Family Health and Research CentersResearch network
- Study start
- Aug 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 Jan 2012 (estimated)
- Results
- Posted 1 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of Licefreee Spray in eradicating head lice as compared to Nix, both are available over-the-counter lice treatments.
Detailed description
Head lice is a worldwide problem. Many treatments for lice appear to be losing their effectiveness; therefore products are needed that safely and effectively eradicate lice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Licefreee Spray | Experimental | Drug: Licefreee Spray |
| Nix Creme Rinse, 1% Permethrin | Active comparator | Drug: 1% permethrin creme rinse |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Must be 4 years of age or older
Key exclusion criteria (6 listed)
- Used any form of head lice treatment, prescription, OTC or home remedy for at least four weeks prior to their visit
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 |
|---|---|---|
| Licefreee SprayLiquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present. | Drug | Licefreee Spray |
| 1% permethrin creme rinseCreme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present. | Drug | Nix Creme Rinse, 1% Permethrin |
Primary outcome
The Proportion Within Each Treatment Group of Subjects Who Have no Live Lice
Time frame: 15 days
No live lice 15 days following initial treatment
1 secondary outcome
Adverse Events
Time frame: 15 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pediculosis Capitis
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Not yet recruiting
Comparative Study for the Evaluation of a New Medical Device Shampoo on the Treatment of Head Lice Infestation
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Efficacy and Safetyof a Medical Device With a Physical Mode of Action (X92001919) Versus Paranix Anti-lice Shampoo.
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Recruiting
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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.
Lidia Serrano principal investigator
South Florida Family Health and Research Centers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Licefreee Spray and 1% permethrin creme rinse in people with Pediculosis Capitis, run by South Florida Family Health and Research Centers at 1 site in United States.
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 5 inclusion and 6 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 1 Jan 2015. 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 States. 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?
Yes. Results are posted in the registry (first posted 1 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Proportion Within Each Treatment Group of Subjects Who Have no Live Lice (time frame: 15 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 1 Jan 2015.