Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ParaPRO LLC
ClinicalTrials.gov Identifier:
NCT00545753
First received: October 15, 2007
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

A comparative safety and efficacy study of NatrOVA Creme Rinse - 1% versus NIX Creme Rinse, under actual use conditions in subjects 6 months of age or greater who are infested with Pediculosis capitis (human head lice).


Condition Intervention Phase
Pediculosis
Drug: Spinosad
Drug: Permethrin 1%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Comparative Safety and Efficacy Study Between NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects >6 Months of Age or Older With Pediculosis Capitis

Resource links provided by NLM:


Further study details as provided by ParaPRO LLC:

Primary Outcome Measures:
  • Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice [ Time Frame: Assessment were made 14 days following the final product treatment ] [ Designated as safety issue: No ]
    The primary efficacy endpoint was the proportion of primary subjects in the enrolled households who were lice free (no live lice, adults or nymphs), as assessed by the trained evaluator, 14 days after the last treatment (i.e., Day 14 for subjects who treated once and Day 21 for subjects who treated twice).


Secondary Outcome Measures:
  • Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. [ Time Frame: Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments) ] [ Designated as safety issue: Yes ]
    To evaluate the safety of NatrOVA® 1% Creme Rinse based upon reported adverse events and observed skin/scalp reactions. Additional safety assessments included cutaneous/ocular irritation.


Enrollment: 558
Study Start Date: September 2007
Study Completion Date: May 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A - NatrOVA 1% - no nit combing
NatrOVA Creme Rinse (spinosad) 1% - no nit combing required
Drug: Spinosad
10 minute topical application product, following by a complete rinse off.
Other Names:
  • Natroba (spinosad) Topical Suspension, 0.9%
  • spinosad
Experimental: B - NatrOVA 1% - nit combing required
NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required
Drug: Spinosad
10 minute topical application followed by a complete rinse off, followed by a nit combing regimen
Other Names:
  • Natroba (spinosad) Topical Suspension, 0.9%
  • spinosad
Active Comparator: C - NIX
NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use
Drug: Permethrin 1%
Topical application for 10 minutes, followed by a complete rinse off, followed by a nit combing regimen
Other Name: NIX Creme Rinse

Detailed Description:

This is a Phase 3 multi-site, randomized, evaluator/investigator-blinded, three-arm, parallel group study evaluating the safety and efficacy of NatrOVA Creme Rinse - 1% (with nit combing and without nit combing) versus NIX Creme Rinse in an "actual use" environment.

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects must have an active head lice infestation present at Day 0.
  2. Subjects can be female or male, at least 6 months of age.
  3. Subjects must be in good general health based on medical history.
  4. Each subject must have an appropriately signed Informed Consent agreement. Subjects under the age of 12 must also provide written or oral assent.
  5. The subject/caregiver must be able to read English or Spanish at a 7th grade level.
  6. The parent or guardian within a household must be willing to allow other household members to be screened for head lice. If other household members are found to have a head lice infestation, they should also be enrolled in the study.
  7. Subjects must agree to not use any other form of lice treatment during the course of the study and must agree not to use any of the excluded concomitant medications.
  8. Subjects must agree not to cut or chemically treat their hair in the period between the initial treatment and the final visit.
  9. Subjects/caregiver must demonstrate a clear understanding of his/her requirements for study participation and agree to comply with study instructions.

Exclusion Criteria:

  1. Individuals with history of irritation or sensitivity to pediculicides or hair care products.
  2. Individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigative personnel or Sponsor, will interfere with the evaluation.
  3. Individuals who require treatment with topical salicylic acid, topical corticosteroids, anthralin, vitamin D analogs, retinoids, immunosuppressants, topical hair growth formulations, and topical dandruff treatments.
  4. Infested subjects who have been previously treated with a pediculicide within the 48 hours prior to the study.
  5. Individuals with a condition or illness that, in the opinion of the Investigator, may compromise the objective of the protocol.
  6. Individuals receiving systemic or topical drugs or medications, including systemic antibiotics, which in the opinion of the investigative personnel or study monitor may interfere with the study results.
  7. Individuals who have participated in a clinical trial within the past 30 days.
  8. Individuals (or individuals from households) who, in the opinion of the Investigator, do not understand the requirements for study participation and/or may be likely to exhibit poor compliance.
  9. Individuals with household 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.
  10. Females who are pregnant or nursing. Females of childbearing potential must have a negative urine pregnancy test prior to treatment at Day 0. If a household has a pregnant female with an active case of head lice, the entire household is excluded from participation. If the pregnant household member does not have lice, this individual must NOT be the caregiver (one who provides treatment to other household members).
  11. Sexually active females not using effective contraception.
  12. Individuals who have a history of drug abuse in the past year.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545753

Locations
United States, Arizona
Hill Top Research
Scottsdale, Arizona, United States, 85251
United States, Arkansas
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
United States, California
Impact Clinical Trials
Beverly Hills, California, United States, 90211
United States, Florida
DMI Healthcare Group
Largo, Florida, United States, 33773
United States, Ohio
Hill Top Research
Miamiville, Ohio, United States, 45147
Haber Dermatology & Cosmetic Surgery
South Euclid, Ohio, United States, 44118
Sponsors and Collaborators
ParaPRO LLC
Investigators
Study Director: Bill Miller, MD Concentrics Research
  More Information

No publications provided

Responsible Party: ParaPRO LLC
ClinicalTrials.gov Identifier: NCT00545753     History of Changes
Other Study ID Numbers: SPN-301-07
Study First Received: October 15, 2007
Results First Received: August 2, 2012
Last Updated: September 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by ParaPRO LLC:
Human 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 July 22, 2014