A Pilot Dose Ranging Study of Spinosad Creme Rinse

A Phase 2a, randomized, single investigational site, investigator/evaluator-blind, four-arm,
parallel-group, vehicle-controlled, pilot study to evaluate the safety and efficacy of
different strengths of Spinosad Creme rinse verses vehicle control.

Inclusion Criteria:

- Active head lice infestation

- Male or female, 2 years of age or older

- Good general health

- Appropriately signed Informed Consent

- 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 between visits

Exclusion Criteria:

- History of irritation or sensitivity to pediculicides or hair care products

- Individuals with any visible skin/scalp condition that would interfere with the
evaluation

- Individuals previously treated with a pediculicide within 4 weeks prior to study
enrollment

- Individuals using hair dyes, bleaches, permanent waves or relaxing solutions 2 weeks
prior to study enrollment

- Individuals who have participated in any clinical trial within 30 days of enrollment

- Individuals with family members who were infested with lice but were unwilling or
unable to enroll in the study or use a standard course of lice treatment

- Females who were pregnant or nursing

- Sexually active females not using effective contraception