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Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice

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ClinicalTrials.gov Identifier: NCT00545753
Recruitment Status : Completed
First Posted : October 17, 2007
Results First Posted : October 11, 2012
Last Update Posted : October 11, 2012
Sponsor:
Information provided by (Responsible Party):
ParaPRO LLC

Tracking Information
First Submitted Date  ICMJE October 15, 2007
First Posted Date  ICMJE October 17, 2007
Results First Submitted Date  ICMJE August 2, 2012
Results First Posted Date  ICMJE October 11, 2012
Last Update Posted Date October 11, 2012
Study Start Date  ICMJE September 2007
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2012)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: October 15, 2007)
Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice [ Time Frame: Assessment will be made 14 days following the final product treatment ]
Change History Complete list of historical versions of study NCT00545753 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2012)
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) ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2007)
Evaluation of the safety of NatrOVA Creme Rinse - 1% based upon reported adv erse events and observed skin/scalp reactions. [ Time Frame: Throughout the study duration ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice
Official Title  ICMJE A Phase 3 Comparative Safety and Efficacy Study Between NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects >6 Months of Age or Older With Pediculosis Capitis
Brief 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 (human 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pediculosis
Intervention  ICMJE
  • Drug: Spinosad
    10 minute topical application product, following by a complete rinse off.
    Other Name: Natroba (spinosad) Topical Suspension, 0.9%
  • Drug: Spinosad
    10 minute topical application followed by a complete rinse off, followed by a nit combing regimen
    Other Name: Natroba (spinosad) Topical Suspension, 0.9%
  • Drug: Permethrin 1%
    Topical application for 10 minutes, followed by a complete rinse off, followed by a nit combing regimen
    Other Name: NIX Creme Rinse
Study Arms  ICMJE
  • Experimental: A - NatrOVA 1% - no nit combing
    NatrOVA Creme Rinse (spinosad) 1% - no nit combing required
    Intervention: Drug: Spinosad
  • Experimental: B - NatrOVA 1% - nit combing required
    NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required
    Intervention: Drug: Spinosad
  • Active Comparator: C - NIX
    NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use
    Intervention: Drug: Permethrin 1%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2012)
558
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2007)
510
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects must have an active head lice infestation present at Day 0.
  2. Subjects can be female or male, at least 6 months of age.
  3. Subjects must be in good general health based on medical history.
  4. Each subject must have an appropriately signed Informed Consent agreement. Subjects under the age of 12 must also provide written or oral assent.
  5. The subject/caregiver must be able to read English or Spanish at a 7th grade level.
  6. 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.
  7. 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.
  8. Subjects must agree not to cut or chemically treat their hair in the period between the initial treatment and the final visit.
  9. Subjects/caregiver must demonstrate a clear understanding of his/her requirements for study participation and agree to comply with study instructions.

Exclusion Criteria:

  1. Individuals with history of irritation or sensitivity to pediculicides or hair care products.
  2. 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.
  3. Individuals who require treatment with topical salicylic acid, topical corticosteroids, anthralin, vitamin D analogs, retinoids, immunosuppressants, topical hair growth formulations, and topical dandruff treatments.
  4. Infested subjects who have been previously treated with a pediculicide within the 48 hours prior to the study.
  5. Individuals with a condition or illness that, in the opinion of the Investigator, may compromise the objective of the protocol.
  6. 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.
  7. Individuals who have participated in a clinical trial within the past 30 days.
  8. 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.
  9. 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.
  10. 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).
  11. Sexually active females not using effective contraception.
  12. Individuals who have a history of drug abuse in the past year.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00545753
Other Study ID Numbers  ICMJE SPN-301-07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ParaPRO LLC
Study Sponsor  ICMJE ParaPRO LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bill Miller, MD Concentrics Research
PRS Account ParaPRO LLC
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP