A Pilot Dose Ranging Study of Spinosad Creme Rinse

Efficacy and Safety of Different Strengths of Spinosad Topical Creme (0%, 0.5%, 1.0% or 2%) in Subjects With Pediculosis Capitis - a Dose Ranging Study

A pilot dose ranging study to evaluate the safety and efficacy of different strengths of Spinosad Creme versus a vehicle control.

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