NCT00858481

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: ParaPRO LLC · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Pediculosis Capitis
• Head Lice

Interventions

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

Timeline

• Start date: 2005-09-01
• Primary completion: 2005-11-01
• Completion: 2005-11-01
• First posted: 2009-03-09
• Last updated: 2015-10-20

Locations

1 site across 1 country: United States