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

This study has been completed.
Sponsor:
Information provided by:
ParaPRO LLC
ClinicalTrials.gov Identifier:
NCT00857935
First received: March 5, 2009
Last updated: March 6, 2009
Last verified: March 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Pediculosis Capitis
Head Lice
 Drug: NatrOVA Creme Rinse - 1%
Drug: NIX Creme Rinse - 1% permethrin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Lice
Drug Information available for: Permethrin
U.S. FDA Resources

Further study details as provided by ParaPRO LLC:

Primary Outcome Measures:
  • Efficacy of NatrOVA Creme Rinse-1% versus NIX Creme rinse, based on the presence or absence of live lice 14 days after the final treatment. [ Time Frame: 14 days after last treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety comparison between NatrOVA Creme Rinse-1% and NIX Creme Rinse, based on the occurrence of adverse events and any increase of scalp and/or ocular irritation, post-treatment. [ Time Frame: 14 days after last treatment ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: March 2007
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
NatrOVA Creme Rinse - 1%
 Drug: NatrOVA Creme Rinse - 1%
NatrOVA Creme Rinse, one or two, 10-minute topical treatments (7 days apart)
Active Comparator: 2
NIX Creme Rinse
 Drug: NIX Creme Rinse - 1% permethrin
NIX Creme Rinse: one or two, 10-minute topical treatments (7 days apart)

Detailed 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.

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00857935

Locations
United States, Indiana
Concentrics Research
Indianapolis, Indiana, United States, 46240
Sponsors and Collaborators
ParaPRO LLC
Investigators
Principal Investigator: Mark Moore, MD Concentrics Research
  More Information

No publications provided

Responsible Party: Mark Moore, MD, Concentrics Research
ClinicalTrials.gov Identifier: NCT00857935     History of Changes
Other Study ID Numbers: SPN-203-07, Concentrics 71007
Study First Received: March 5, 2009
Last Updated: March 6, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by ParaPRO LLC:
Pediculosis Capitis
Head Lice

Additional relevant MeSH terms:
Lice Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
Skin Diseases, Infectious
 Skin Diseases
Permethrin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013