A Pilot Dose Ranging Study of Spinosad Creme Rinse

Completed · Phase 2

Conditions studied: Pediculosis Capitis, Head Lice

In brief

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

Key facts

Study ID

NCT00858481

Run by

ParaPRO LLC

People needed

36

Starts

2005-09-01

Expected to finish

2005-11-01

Last updated by the study team

2015-10-20

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hill Top Research — West Palm Beach, Florida, United States

Full record on ClinicalTrials.gov

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