A Pilot Dose Ranging Study of Spinosad Creme Rinse

ParaPRO LLC36 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pediculosis Capitis Head Lice

Interventions

Spinosad Creme Rinse - Vehicle ControlDRUG

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

Spinosad Creme RinseDRUG

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

Spinosad Creme RinseDRUG

1.0% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart)

Eligibility

Sex: ALLMin age: 2 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hill Top Research

West Palm Beach, Florida, United States

Outcomes

Primary Outcomes

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

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

Time frame: 14 days

Data from ClinicalTrials.gov

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