Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice
Condition: Pediculosis
MeSH terms: Lice Infestations
Intervention: Spinosad; Spinosad; Permethrin 1%
Intervention description: 10 minute topical application product, following by a complete rinse off.; 10 minute topical application followed by a complete rinse off, followed by a nit combing regimen; Topical application for 10 minutes, followed by a complete rinse off, followed by a nit combing regimen
Intervention MeSH terms: Permethrin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Enrollment: 558.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Human Head lice

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).
    

Eligibility criteria:

        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.