Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice
Information source: ParaPRO LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pediculus Capitis Infestation
Intervention: Spinosad (Drug); Spinosad (Drug); Permethrin 1% (Drug)
Phase: Phase 3
Sponsored by: ParaPRO LLC
Official(s) and/or principal investigator(s):
Bill Miller, MD, Study Director, Affiliation: Concentrics Research
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 (Head lice).
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 With Pediculosis Capitis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice
Secondary outcome: Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions.
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.
Minimum age: 6 Months.
Maximum age: N/A.
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.
1. Individuals with history of irritation or sensitivity to pediculicides or hair care
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
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
11. Sexually active females not using effective contraception.
12. Individuals who have a history of drug abuse in the past year.
Locations and Contacts
Advanced Dermatology and Cosmetic Surgery, Ormond Beach, Florida 32174, United States
Lice Solutions Network, Inc., West Palm Beach, Florida 33407, United States
Concentrics Center for Research, Indianapolis, Indiana 46240, United States
Alegent Health Clinic, Council Bluffs, Iowa 51503, United States
Celia Reyes-Acuna, Corpus Christi, Texas 78411, United States
Wee Care Pediatrics, Layton, Utah 84041, United States
Starting date: September 2007
Last updated: September 10, 2012