Pediculosis CapitisPhase 2NCT00857935
A Safety and Efficacy Pilot Study Comparing NatrOVA Creme Rinse 1% and NIX Creme Rinse
A Phase 2 study testing NatrOVA Creme Rinse - 1% and NIX Creme Rinse - 1% permethrin in people with Pediculosis Capitis and Head Lice, run by ParaPRO LLC at 1 site in United States.
Trial summary
A pilot study to compare the safety and efficacy of NatrOVA Creme Rinse 1% to NIX Creme Rinse in subjects with Pediculosis Capitis Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Pediculosis Capitis, Head Lice
- What is being tested?
- NatrOVA Creme Rinse - 1% and NIX Creme Rinse - 1% permethrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Apr 2007
- 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 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male or female, 6 months of age or older
- Subject must have a head lice infestation present at baseline
- Subject/caregiver must read English or Spanish at a 7th grade level
- Subject must have an appropriately signed Informed Consent agreement
- Other members of the household with a lice infestation must be willing to be enrolled in the study or treat their infestations with a standard treatment
- Subject agreement to not use any other form of lice treatment during the course of the study
- Subject agreement to not cut or chemically treat their hair in the period between baseline and final, post-treatment visits
Who cannot join
- Individuals with a history of irritation or sensitivity to pediculicides or hair care products
- Individuals with any visible skin/scalp condition at the treatment site that could interfere with the evaluation
- Individuals previously treated with a pediculicide or any other head lice treatment product within 48 hours prior to enrollment
- Individuals receiving systemic or topical drugs that may interfere with the study results
- Individuals who have participated in a clinical trial within 30 days of enrollment
- Individuals with family 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
- Sexually-active females not using effective contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Test the Operational Elements of an Actual Use Study Designed to Compare the Safety and Efficacy of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months of Age or Older With Pediculosis Capitis
A pilot study to compare the safety and efficacy of NatrOVA Creme Rinse 1% to NIX Creme Rinse in subjects with Pediculosis Capitis
Read the detailed description
A Phase 2b, randomized, single-site, investigator/evaluator blind, two-arm, parallel-group pilot study that tested the operational elements of an "Actual Use" study designed to evaluate the safety and efficacy of a 10-minute treatment and no-nit combing regimen of NatrOVA Creme Rinse 1% versus NIX Creme Rinse in subjects with at least a mild case of head lice.
- Conditions
- Pediculosis Capitis, Head Lice
- Being tested
- NatrOVA Creme Rinse - 1%, NIX Creme Rinse - 1% permethrin
- Keywords
- Pediculosis Capitis, Head Lice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NatrOVA Creme Rinse - 1%Drug
NatrOVA Creme Rinse, one or two, 10-minute topical treatments (7 days apart)
NIX Creme Rinse - 1% permethrinDrug
NIX Creme Rinse: one or two, 10-minute topical treatments (7 days apart)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | NatrOVA Creme Rinse - 1% Receives: Drug: NatrOVA Creme Rinse - 1% |
| 2 | Active comparator | NIX Creme Rinse Receives: Drug: NIX Creme Rinse - 1% permethrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of NatrOVA Creme Rinse-1% versus NIX Creme rinse, based on the presence or absence of live lice 14 days after the final treatment.
Measured: 14 days after last treatment
Secondary outcomes (1)
Safety comparison between NatrOVA Creme Rinse-1% and NIX Creme Rinse, based on the occurrence of adverse events and any increase of scalp and/or ocular irritation, post-treatment.
Measured: 14 days after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startMar 2007
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- ParaPRO LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark Moore, MD, Principal investigator, Concentrics Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857935
- Sponsor's protocol ID
- SPN-203-07
- Other IDs
- Concentrics 71007
- Status last verified
- Mar 2009
- First submitted
- 5 Mar 2009
- Last updated
- 9 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Test the Operational Elements of an Actual Use Study Designed to Compare the Safety and Efficacy of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months of Age or Older With Pediculosis Capitis
- ClinicalTrials.gov ID
- NCT00857935
- Acronym / sponsor ID
- SPN-203-07
- Conditions
- Pediculosis Capitis, Head Lice
- Keywords
- Pediculosis Capitis, Head Lice
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- ParaPRO LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 9 Mar 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.
A pilot study to compare the safety and efficacy of NatrOVA Creme Rinse 1% to NIX Creme Rinse in subjects with Pediculosis Capitis
Detailed description
A Phase 2b, randomized, single-site, investigator/evaluator blind, two-arm, parallel-group pilot study that tested the operational elements of an "Actual Use" study designed to evaluate the safety and efficacy of a 10-minute treatment and no-nit combing regimen of NatrOVA Creme Rinse 1% versus NIX Creme Rinse in subjects with at least a mild case of head lice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: NatrOVA Creme Rinse - 1%NatrOVA Creme Rinse - 1% |
| 2 | Active comparator | Drug: NIX Creme Rinse - 1% permethrinNIX Creme Rinse |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, 6 months of age or older
- Subject must have a head lice infestation present at baseline
- Subject/caregiver must read English or Spanish at a 7th grade level
- Subject must have an appropriately signed Informed Consent agreement
- Other members of the household with a lice infestation must be willing to be enrolled in the study or treat their infestations with a standard treatment
Key exclusion criteria (8 listed)
- Individuals with a history of irritation or sensitivity to pediculicides or hair care products
- Individuals with any visible skin/scalp condition at the treatment site that could interfere with the evaluation
- Individuals previously treated with a pediculicide or any other head lice treatment product within 48 hours prior to enrollment
- Individuals receiving systemic or topical drugs that may interfere with the study results
- Individuals who have participated in a clinical trial within 30 days of enrollment
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 |
|---|---|---|
| NatrOVA Creme Rinse - 1%NatrOVA Creme Rinse, one or two, 10-minute topical treatments (7 days apart) | Drug | 1 |
| NIX Creme Rinse - 1% permethrinNIX Creme Rinse: one or two, 10-minute topical treatments (7 days apart) | Drug | 2 |
Primary outcome
Efficacy of NatrOVA Creme Rinse-1% versus NIX Creme rinse, based on the presence or absence of live lice 14 days after the final treatment.
Time frame: 14 days after last treatment
1 secondary outcome
Safety comparison between NatrOVA Creme Rinse-1% and NIX Creme Rinse, based on the occurrence of adverse events and any increase of scalp and/or ocular irritation, post-treatment.
Time frame: 14 days after last 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 9 Mar 2009.
Related trials for Pediculosis Capitis
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.
Mark Moore, MD principal investigator
Concentrics Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NatrOVA Creme Rinse - 1% and NIX Creme Rinse - 1% permethrin in people with Pediculosis Capitis and Head Lice, run by ParaPRO LLC 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 7 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 9 Mar 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 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 of NatrOVA Creme Rinse-1% versus NIX Creme rinse, based on the presence or absence of live lice 14 days after the final treatment. (time frame: 14 days after last 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 9 Mar 2009.