Trial | NCT00857935  Report issue

Title

A Safety and Efficacy Pilot Study Comparing NatrOVA Creme Rinse 1% and NIX Creme Rinse
A Pilot Study to Test the Operational Elements of an Actual Use Study Designed to Compare the Safety and Efficacy of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months of Age or Older With Pediculosis Capitis

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    permethrin spinosad ...

  • Study Participants

    24
A pilot study to compare the safety and efficacy of NatrOVA Creme Rinse 1% to NIX Creme Rinse in subjects with Pediculosis Capitis
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.
Study Started
Mar 31
2007
Primary Completion
Apr 30
2007
Study Completion
Apr 30
2007
Last Update
Mar 09
2009
Estimate

Drug NatrOVA Creme Rinse - 1%

NatrOVA Creme Rinse, one or two, 10-minute topical treatments (7 days apart)

Drug NIX Creme Rinse - 1% permethrin

NIX Creme Rinse: one or two, 10-minute topical treatments (7 days apart)

1 Experimental

NatrOVA Creme Rinse - 1%

2 Active Comparator

NIX Creme Rinse

Criteria 

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
No Results Posted