A Pilot Dose Ranging Study of Spinosad Creme Rinse

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: November 2005

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.

Interventions

  • 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)

Arms, Groups and Cohorts

  • Placebo Comparator: 1
    • Vehicle control
  • Active Comparator: 2
    • 0.5% Spinosad creme rinse
  • Active Comparator: 3
    • 1.0% Spinosad Creme Rinse
  • Active Comparator: 4
    • 2.0% Spinosad Creme Rinse

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Safety of various doses of Spinosad, based on the occurrence of adverse events, especially scalp irritation.
    • Time Frame: 14 days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • ParaPRO LLC
  • Provider of Information About this Clinical Study
    • Dyal Garg, Ph.D., Principal Investigator, Hill Top Research
  • Overall Official(s)
    • Dyal Garg, Ph.D., Principal Investigator, Hill Top Research

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