Pediculosis Capitis (Head Lice)Phase 2NCT00311779
A Dose Ranging Study of Different Strengths of Spinosad Topical Creme in Subjects With Pediculosis Capitis
A Phase 2 study testing Spinosad Creme Rinse in people with Pediculosis Capitis (Head Lice), run by ParaPRO LLC at 3 sites in United States.
Trial summary
The primary objective of the study is to determine the safety and efficacy of different strengths of Spinosad topical creme, as compared to a vehicle control, in subjects who have been infested with at least a mild case of Pediculosis capitis (head lice). Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pediculosis Capitis (Head Lice)
- What is being tested?
- Spinosad Creme Rinse
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2006to Jul 2006
- Phase
- Phase 2
- 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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subject must have head lice infestation of at least a mild severity present at baseline of at least 3 live lice and the presence of nits;
- Subject can be either male or female, 2 years or older
- Subject must be in good general health, based on medical history.
- Each subject must have a appropriately signed informed consent.
- The parent or guardian of a child subject must be willing to allow other household members to be screened for head lice. If other household members are found to have a head lice infestation, they should also be enrolled in the study. If other household members are not willing to enroll in the study or do not qualify for enrollment, they must be willing to use the standard course of OTC lice treatment at home.
- Subjects must agree to not use any other form of lice treatment during the course of the study. Subjects must also agree not to use a lice comb during the course of the study.
- Subjects must agree not to cut or chemically treat their hair in the period between the Baseline treatment and the Day 14 visit.
Who cannot join
- Individuals with history of irritation or sensitivity to pediculicides or hair care products.
- Individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigative personnel, will interfere with the evaluation.
- Individuals previously treated with a pediculicide within the 4 weeks prior to the study.
- Individuals who have used hair dyes, bleaches, permanent wave or relaxing solutions within the past 2 weeks or during the study.
- Individuals with a condition or illness that, in the opinion of the investigator, may compromise the objective of the protocol.
- Individuals receiving systemic or topical drugs or medications, including systemic antibiotics, which in the opinion of the investigative personnel may interfere with the study results.
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- Individuals who have participated in a clinical trial within the past 30 days.
- Individuals who, in the opinion of the investigator, do not understand the subject requirements for study participation and/or may be likely to exhibit poor compliance.
- Individuals with family members who are infested with lice but are unwilling or unable to enroll in the study or to ouse the standard course of lice treatment.
- Females who are pregnant or nursing.
- Sexually active females not using effective contraception.
- Individuals who have a history of drug abuse in the past year.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hill Top Research
Miamiville, Ohio, 45147
Hill Top Resesarch
Scottsdale, Arizona, 85251
Hill Top Research
West Palm Beach, Florida, 33409
About this study
Official title: Phase 2 Study of Efficacy and Safety of Different Strengths of Spinosad Topical Creme Rinse (0%, 0.5% or 1.0%) in Subjects 2 Years of Age or Older With Pediculosis Capitis - A Dose Ranging Study
The primary objective of the study is to determine the safety and efficacy of different strengths of Spinosad topical creme, as compared to a vehicle control, in subjects who have been infested with at least a mild case of Pediculosis capitis (head lice).
Read the detailed description
There are millions of children and adults affected with head lice each year in the United States. It has become a major nuisance in school children resulting in many lost school days and frustrated parents. Lice and nit (ova) resistance to current OTC products has been reported. Compliance with product instructions is thought to be low. Therefore a safe and effective alternative to these products is desirable.
Spinosad and its formulations have been approved by the Environmental Protection Agency as crop protection products in the US, Canada and Australia, and has received provisional approval in the UK, Spain and several other European Union countries.
Spinosad is being formulated as a creme rinse using excipients that are widely used and are "generally regarded as safe" (GRAS).
This study is intended to show the safety and efficacy of Spinosad 0.5% and 1.0%, as compared to the vehicle control in subjects 2 years of age and older with at least a mild infestation of pediculosis capitis.
- Conditions
- Pediculosis Capitis (Head Lice)
- Being tested
- Spinosad Creme Rinse
- Keywords
- Pediculosis capitis, Head Lice, Crawlers, Ova
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinosad Creme RinseDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy variable: The presence/absence of live lice and/or nits at Day 7 and Day 14.
Safety Analyses: The assessment of safety will be based on frequency of adverse events and on the scalp evaluations for irritation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2006 (estimated)
- Study startMar 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediculosis Capitis (Head Lice)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- ParaPRO LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dyal Garg, PhD, Principal investigator, Hill Top ResearchRobert Lewine, MD, Principal investigator, Hill Top ResearchMichael Noss, MD, Principal investigator, Hill Top Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311779
- Sponsor's protocol ID
- SPN-202-06
- Status last verified
- Jul 2006
- First submitted
- 4 Apr 2006
- Last updated
- 12 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Efficacy and Safety of Different Strengths of Spinosad Topical Creme Rinse (0%, 0.5% or 1.0%) in Subjects 2 Years of Age or Older With Pediculosis Capitis - A Dose Ranging Study
- ClinicalTrials.gov ID
- NCT00311779
- Acronym / sponsor ID
- SPN-202-06
- Conditions
- Pediculosis Capitis (Head Lice)
- Keywords
- Pediculosis capitis, Head Lice, Crawlers, Ova
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- ParaPRO LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Study completion
- Jul 2006
- First posted
- 6 Apr 2006 (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.
The primary objective of the study is to determine the safety and efficacy of different strengths of Spinosad topical creme, as compared to a vehicle control, in subjects who have been infested with at least a mild case of Pediculosis capitis (head lice).
Detailed description
There are millions of children and adults affected with head lice each year in the United States. It has become a major nuisance in school children resulting in many lost school days and frustrated parents. Lice and nit (ova) resistance to current OTC products has been reported. Compliance with product instructions is thought to be low. Therefore a safe and effective alternative to these products is desirable.
Spinosad and its formulations have been approved by the Environmental Protection Agency as crop protection products in the US, Canada and Australia, and has received provisional approval in the UK, Spain and several other European Union countries.
Spinosad is being formulated as a creme rinse using excipients that are widely used and are "generally regarded as safe" (GRAS).
This study is intended to show the safety and efficacy of Spinosad 0.5% and 1.0%, as compared to the vehicle control in subjects 2 years of age and older with at least a mild infestation of pediculosis capitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Subject must have head lice infestation of at least a mild severity present at baseline of at least 3 live lice and the presence of nits;
- Subject can be either male or female, 2 years or older
- Subject must be in good general health, based on medical history.
- Each subject must have a appropriately signed informed consent.
- The parent or guardian of a child subject must be willing to allow other household members to be screened for head lice. If other household members are found to have a head lice infestation, they should also be enrolled in the study. If other household members are not willing to enroll in the study or do not qualify for enrollment, they must be willing to use the standard course of OTC lice treatment at home.
Key exclusion criteria (12 listed)
- Individuals with history of irritation or sensitivity to pediculicides or hair care products.
- Individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigative personnel, will interfere with the evaluation.
- Individuals previously treated with a pediculicide within the 4 weeks prior to the study.
- Individuals who have used hair dyes, bleaches, permanent wave or relaxing solutions within the past 2 weeks or during the study.
- Individuals with a condition or illness that, in the opinion of the investigator, may compromise the objective of the protocol.
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 |
|---|---|---|
| Spinosad Creme Rinse | Drug | – |
Primary outcome
Efficacy variable: The presence/absence of live lice and/or nits at Day 7 and Day 14.
Safety Analyses: The assessment of safety will be based on frequency of adverse events and on the scalp evaluations for irritation.
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 12 Jul 2006.
Related trials for Pediculosis Capitis (Head Lice)
Recruiting
Safety, Efficacy and Preventative Effect of a Head Lice Product (X92001483) vs. Nix Creme Rinse (1% Permethrin).
Lice; Head Lice
Not yet recruiting
Comparative Study for the Evaluation of a New Medical Device Shampoo on the Treatment of Head Lice Infestation
Headlice
Not yet recruiting
Efficacy and Safetyof a Medical Device With a Physical Mode of Action (X92001919) Versus Paranix Anti-lice Shampoo.
Lice; Head Lice
Recruiting
Safety and Efficacy of Head-lice Treatments Elimax Green Lotion and Walgreens Lice Killing Shampoo
Head Lice
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.
Dyal Garg, PhD principal investigator
Hill Top Research
Robert Lewine, MD principal investigator
Hill Top Research
Michael Noss, MD principal investigator
Hill Top Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spinosad Creme Rinse in people with Pediculosis Capitis (Head Lice), run by ParaPRO LLC at 3 sites 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 7 inclusion and 12 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 12 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Efficacy variable: The presence/absence of live lice and/or nits at Day 7 and Day 14.. The study lists 2 primary outcomes in all. 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 12 Jul 2006.