Trial | NCT00858481  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    spinosad ...

  • Study Participants

    36
A pilot dose ranging study to evaluate the safety and efficacy of different strengths of Spinosad Creme versus a vehicle control.
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 Started
Sep 30
2005
Primary Completion
Nov 30
2005
Study Completion
Nov 30
2005
Last Update
Oct 20
2015
Estimate

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)

1 Placebo Comparator

Vehicle control

2 Active Comparator

0.5% Spinosad creme rinse

3 Active Comparator

1.0% Spinosad Creme Rinse

4 Active Comparator

2.0% Spinosad Creme Rinse

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
No Results Posted