Pediculus Capitis InfestationPhase 3NCT00545168
Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice
A Phase 3 study testing Spinosad and Permethrin 1% in people with Pediculus Capitis Infestation, run by ParaPRO LLC at 6 sites in United States.
Trial summary
A comparative safety and efficacy study of NatrOVA Creme Rinse - 1% versus NIX Creme Rinse, under actual use conditions in subjects 6 months of age or greater who are infested with Pediculosis capitis (Head lice). Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Pediculus Capitis Infestation
- What is being tested?
- Spinosad and Permethrin 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2007to May 2008
- Phase
- Phase 3
- 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 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subjects must have an active head lice infestation present at Day 0.
- Subjects can be female or male, at least 6 months of age.
- Subjects must be in good general health based on medical history.
- Each subject must have an appropriately signed Informed Consent agreement. Subjects under the age of 12 must also provide written or oral assent.
- The subject/caregiver must be able to read English or Spanish at a 7th grade level.
- The parent or guardian within a household 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.
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- Subjects must agree to not use any other form of lice treatment during the course of the study and must agree not to use any of the excluded concomitant medications.
- Subjects must agree not to cut or chemically treat their hair in the period between the initial treatment and the final visit.
- Subjects/caregiver must demonstrate a clear understanding of his/her requirements for study participation and agree to comply with study instructions.
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 or Sponsor, will interfere with the evaluation.
- Individuals who require treatment with topical salicylic acid, topical corticosteroids, anthralin, vitamin D analogs, retinoids, immunosuppressants, topical hair growth formulations, and topical dandruff treatments.
- Infested subjects who have been previously treated with a pediculicide within the 48 hours prior to 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 or study monitor may interfere with the study results.
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- Individuals who have participated in a clinical trial within the past 30 days.
- Individuals (or individuals from households) who, in the opinion of the Investigator, do not understand the requirements for study participation and/or may be likely to exhibit poor compliance.
- Individuals with household members who are infested with lice but are unwilling or unable to enroll in the study or to use the standard course of lice treatment.
- Females who are pregnant or nursing. Females of childbearing potential must have a negative urine pregnancy test prior to treatment at Day 0. If a household has a pregnant female with an active case of head lice, the entire household is excluded from participation. If the pregnant household member does not have lice, this individual must NOT be the caregiver (one who provides treatment to other household members).
- Sexually active females not using effective contraception.
- Individuals who have a history of drug abuse in the past year.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Celia Reyes-Acuna
Corpus Christi, Texas, 78411
Alegent Health Clinic
Council Bluffs, Iowa, 51503
Concentrics Center for Research
Indianapolis, Indiana, 46240
Wee Care Pediatrics
Layton, Utah, 84041
Advanced Dermatology and Cosmetic Surgery
Ormond Beach, Florida, 32174
Lice Solutions Network, Inc.
West Palm Beach, Florida, 33407
About this study
Official title: A Phase 3 Comparative Safety and Efficacy Study Between NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects > 6 Months of Age With Pediculosis Capitis
A comparative safety and efficacy study of NatrOVA Creme Rinse - 1% versus NIX Creme Rinse, under actual use conditions in subjects 6 months of age or greater who are infested with Pediculosis capitis (Head lice).
Read the detailed description
This is a Phase 3 multi-site, randomized, evaluator/investigator-blinded, three-arm, parallel group study evaluating the safety and efficacy of NatrOVA Creme Rinse - 1% (with nit combing and without nit combing) versus NIX Creme Rinse in an "actual use" environment.
- Conditions
- Pediculus Capitis Infestation
- Being tested
- Spinosad, Permethrin 1%
- Keywords
- head lice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpinosadDrug
Also called Natroba (spinosad) Topical Suspension, 0.9%
10 minute topical application of product, followed by a complete rinse off.
SpinosadDrug
Also called Natroba (spinosad) Topical Suspension, 0.9%
10 minute topical application followed by a complete rinse off, followed by a nit combing regimen.
Permethrin 1%Drug
Also called NIX Creme Rinse
Topical application for 10 minutes, followed by a complete rinse off, followed by a nit combing regimen
| Study group | Role | What they receive |
|---|---|---|
| A - NatrOVA 1% - no nit combing | Experimental | NatrOVA Creme Rinse (spinosad) 1% - no nit combing required Receives: Drug: Spinosad |
| B - NatrOVA 1% - nit combing required | Experimental | NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required Receives: Drug: Spinosad |
| C - NIX | Active comparator | Nix Creme Rinse (permethrin 1%) applied according to OTC Instructions for Use Receives: Drug: Permethrin 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice
The primary efficacy endpoint was the proportion of primary subjects in the enrolled households who were lice free (no live lice, adults or nymphs), as assessed by the trained evaluator, 14 days after the last treatment (i.e., Day 14 for subjects who treated once and Day 21 for subjects who treated twice).
Measured: Assessment were made 14 days following the final product treatment
Secondary outcomes (1)
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions.
To evaluate the safety of NatrOVA® 1% Creme Rinse based upon reported adverse events and observed skin/scalp reactions. Additional safety assessments included cutaneous/ocular irritation.
Measured: Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionMar 2008
- Study completionMay 2008
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 Pediculus Capitis InfestationStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- ParaPRO LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bill Miller, MD, Study director, Concentrics Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545168
- Sponsor's protocol ID
- SPN-302-07
- Status last verified
- Sep 2012
- First submitted
- 15 Oct 2007
- Last updated
- 11 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Comparative Safety and Efficacy Study Between NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects > 6 Months of Age With Pediculosis Capitis
- ClinicalTrials.gov ID
- NCT00545168
- Acronym / sponsor ID
- SPN-302-07
- Conditions
- Pediculus Capitis Infestation
- Keywords
- head lice
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- ParaPRO LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 17 Oct 2007 (estimated)
- Results
- Posted 11 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A comparative safety and efficacy study of NatrOVA Creme Rinse - 1% versus NIX Creme Rinse, under actual use conditions in subjects 6 months of age or greater who are infested with Pediculosis capitis (Head lice).
Detailed description
This is a Phase 3 multi-site, randomized, evaluator/investigator-blinded, three-arm, parallel group study evaluating the safety and efficacy of NatrOVA Creme Rinse - 1% (with nit combing and without nit combing) versus NIX Creme Rinse in an "actual use" environment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A - NatrOVA 1% - no nit combing | Experimental | Drug: SpinosadNatrOVA Creme Rinse (spinosad) 1% - no nit combing required |
| B - NatrOVA 1% - nit combing required | Experimental | Drug: SpinosadNatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required |
| C - NIX | Active comparator | Drug: Permethrin 1%Nix Creme Rinse (permethrin 1%) applied according to OTC Instructions for Use |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects must have an active head lice infestation present at Day 0.
- Subjects can be female or male, at least 6 months of age.
- Subjects must be in good general health based on medical history.
- Each subject must have an appropriately signed Informed Consent agreement. Subjects under the age of 12 must also provide written or oral assent.
- The subject/caregiver must be able to read English or Spanish at a 7th grade level.
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 or Sponsor, will interfere with the evaluation.
- Individuals who require treatment with topical salicylic acid, topical corticosteroids, anthralin, vitamin D analogs, retinoids, immunosuppressants, topical hair growth formulations, and topical dandruff treatments.
- Infested subjects who have been previously treated with a pediculicide within the 48 hours prior to 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 |
|---|---|---|
| SpinosadAlso: Natroba (spinosad) Topical Suspension, 0.9%10 minute topical application of product, followed by a complete rinse off. | Drug | A - NatrOVA 1% - no nit combing |
| SpinosadAlso: Natroba (spinosad) Topical Suspension, 0.9%10 minute topical application followed by a complete rinse off, followed by a nit combing regimen. | Drug | B - NatrOVA 1% - nit combing required |
| Permethrin 1%Also: NIX Creme RinseTopical application for 10 minutes, followed by a complete rinse off, followed by a nit combing regimen | Drug | C - NIX |
Primary outcome
Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice
Time frame: Assessment were made 14 days following the final product treatment
The primary efficacy endpoint was the proportion of primary subjects in the enrolled households who were lice free (no live lice, adults or nymphs), as assessed by the trained evaluator, 14 days after the last treatment (i.e., Day 14 for subjects who treated once and Day 21 for subjects who treated twice).
1 secondary outcome
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions.
Time frame: Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bill Miller, MD study director
Concentrics Research
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Spinosad and Permethrin 1% in people with Pediculus Capitis Infestation, run by ParaPRO LLC at 6 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 9 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 11 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 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?
Yes. Results are posted in the registry (first posted 11 Oct 2012). 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?
Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice (time frame: Assessment were made 14 days following the final product treatment). 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 11 Oct 2012.