A Safety and Efficacy Pilot Study Comparing NatrOVA Creme Rinse 1% and NIX Creme Rinse

ParaPRO

Status and phase

Completed

Phase 2

Conditions

Head Lice

Pediculosis Capitis

Treatments

Drug: NatrOVA Creme Rinse - 1%

Drug: NIX Creme Rinse - 1% permethrin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00857935

SPN-203-07

Concentrics 71007

Details and patient eligibility

About

A pilot study to compare the safety and efficacy of NatrOVA Creme Rinse 1% to NIX Creme Rinse in subjects with Pediculosis Capitis

Full description

A Phase 2b, randomized, single-site, investigator/evaluator blind, two-arm, parallel-group pilot study that tested the operational elements of an "Actual Use" study designed to evaluate the safety and efficacy of a 10-minute treatment and no-nit combing regimen of NatrOVA Creme Rinse 1% versus NIX Creme Rinse in subjects with at least a mild case of head lice.

Enrollment

24 patients

Sex

All

Ages

6+ months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female, 6 months of age or older
Subject must have a head lice infestation present at baseline
Subject/caregiver must read English or Spanish at a 7th grade level
Subject must have an appropriately signed Informed Consent agreement
Other members of the household with a lice infestation must be willing to be enrolled in the study or treat their infestations with a standard treatment
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 in the period between baseline and final, post-treatment visits

Exclusion criteria

Individuals with a history of irritation or sensitivity to pediculicides or hair care products
Individuals with any visible skin/scalp condition at the treatment site that could interfere with the evaluation
Individuals previously treated with a pediculicide or any other head lice treatment product within 48 hours prior to enrollment
Individuals receiving systemic or topical drugs that may interfere with the study results
Individuals who have participated in a clinical trial within 30 days of enrollment
Individuals with family members who are infested with lice but are unwilling or unable to enroll in the study or to use the standard course of lice treatment
Females who are pregnant or nursing
Sexually-active females not using effective contraception