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.

• Spinosad Creme Rinse - Vehicle Control (Drug): One or two, 10-minute topical applications (7 days apart)
• Spinosad Creme Rinse (Drug): 0.5% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart)
• Spinosad Creme Rinse (Drug): 1.0% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart)
• Spinosad Creme Rinse (Drug): 2.0% Spinosad Creme Rinse - one or two, 10-minute topical applications (7 days apart)

Primary outcomes

• Efficacy of various doses of Spinosad, based on the presence or absence of live lice at 7 and 14 days post-treatment. The efficacy evaluation was performed by a trained evaluator. [14 days]

Secondary outcomes

• Safety of various doses of Spinosad, based on the occurrence of adverse events, especially scalp irritation. [14 days]

Sex: All, ages: 2 Years to any, accepts healthy volunteers

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

• Dyal Garg, Ph.D., Principal investigator, Hill Top Research