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

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.

What this study is about