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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00857935
Recruitment Status : Completed
First Posted : March 9, 2009
Last Update Posted : March 9, 2009
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Brief Summary:
A pilot study to compare the safety and efficacy of NatrOVA Creme Rinse 1% to NIX Creme Rinse in subjects with Pediculosis Capitis

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : March 2007
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Permethrin

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00857935

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United States, Indiana
Concentrics Research
Indianapolis, Indiana, United States, 46240
Sponsors and Collaborators
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Principal Investigator: Mark Moore, MD Concentrics Research

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Responsible Party: Mark Moore, MD, Concentrics Research Identifier: NCT00857935     History of Changes
Other Study ID Numbers: SPN-203-07
Concentrics 71007
First Posted: March 9, 2009    Key Record Dates
Last Update Posted: March 9, 2009
Last Verified: March 2009

Keywords provided by ParaPRO LLC:
Pediculosis Capitis
Head Lice

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