A Pilot Dose Ranging Study of Spinosad Creme Rinse

Phase 2

Completed

• Conditions: Pediculosis Capitis; Head Lice
• Interventions: Drug: Spinosad Creme Rinse - Vehicle Control; Drug: Spinosad Creme Rinse

• Registration Number: NCT00858481
• Lead Sponsor: ParaPRO LLC

Brief 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.

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Study First Submitted: 2009-03-05
• Study First Submitted QC: 2009-03-06
• Study First Posted: 2009-03-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-19
• Last Update Posted: 2015-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Spinosad Creme Rinse - Vehicle Control	Vehicle control
4	Spinosad Creme Rinse	2.0% Spinosad Creme Rinse
3	Spinosad Creme Rinse	1.0% Spinosad Creme Rinse
2	Spinosad Creme Rinse	0.5% Spinosad creme rinse

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Safety of various doses of Spinosad, based on the occurrence of adverse events, especially scalp irritation.	14 days

Trial Locations

Locations (1)

Hill Top Research; 🇺🇸 West Palm Beach, Florida, United States