A Pilot Dose Ranging Study of Spinosad Creme Rinse

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ParaPRO LLC

Criteria

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