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

P

ParaPRO

Status and phase

Completed
Phase 2

Conditions

Head Lice
Pediculosis Capitis

Treatments

Drug: NIX Creme Rinse - 1% permethrin
Drug: NatrOVA Creme Rinse - 1%

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

24 participants in 2 patient groups

1
Experimental group
Description:
NatrOVA Creme Rinse - 1%
Treatment:
Drug: NatrOVA Creme Rinse - 1%
2
Active Comparator group
Description:
NIX Creme Rinse
Treatment:
Drug: NIX Creme Rinse - 1% permethrin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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