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Completed

NCT Number: NCT00858481

A Pilot Dose Ranging Study of Spinosad Creme Rinse

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

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Key information

Conditions

Pediculosis Capitis Head Lice

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hill Top Research

West Palm Beach, Florida, 33409, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinosad Creme Rinse - Vehicle Control

Drug

One or two, 10-minute topical applications (7 days apart)

Spinosad Creme Rinse

Drug

0.5% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart)

Primary outcomes

  1. 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.

    Time frame: 14 days

Secondary outcomes

  1. Safety of various doses of Spinosad, based on the occurrence of adverse events, especially scalp irritation.

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

ParaPRO LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Mar 9, 2009
Registry last updated
Oct 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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