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

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.

• Spinosad (Drug), also known as Natroba (spinosad) Topical Suspension, 0.9%: 10 minute topical application of product, followed by a complete rinse off.
• Spinosad (Drug), also known as 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 known as NIX Creme Rinse: Topical application for 10 minutes, followed by a complete rinse off, followed by a nit combing regimen

Primary outcomes

• Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice [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).

Secondary outcomes

• Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. [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.

Sex: All, ages: 6 Months to any, accepts healthy volunteers

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.

Participant flow

Outcome results

• Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. (Secondary), Number, Incidents: A/B - NatrOVA 1% - With/Without Nit Combing 1; C - NIX 0
• Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice (Primary), Number, participants: A - NatrOVA 1% - no Nit Combing 72; B - NatrOVA 1% - Nit Combing Required 17; C - NIX 36

Adverse events

Time frame: Through out the study (7 months).

Serious adverse events by term

Other adverse events by term

• Bill Miller, MD, Study director, Concentrics Research