Clinical trial NCT00545168: Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pediculus Capitis Infestation
Keywords: head lice
Lead sponsor: ParaPRO LLC
Sponsor class: INDUSTRY
First posted: 2007-10-17
Enrollment: 480
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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 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.

Primary outcomes:
measure: Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice
timeFrame: Assessment were made 14 days following the final product treatment
Secondary outcomes:
measure: Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions.
timeFrame: Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments)
Other outcomes:
Locations:
city: Ormond Beach
country: United States
facility: Advanced Dermatology and Cosmetic Surgery
state: Florida
city: West Palm Beach
country: United States
facility: Lice Solutions Network, Inc.
state: Florida
city: Indianapolis
country: United States
facility: Concentrics Center for Research
state: Indiana
city: Council Bluffs
country: United States
facility: Alegent Health Clinic
state: Iowa
city: Corpus Christi
country: United States
facility: Celia Reyes-Acuna
state: Texas
city: Layton
country: United States
facility: Wee Care Pediatrics
state: Utah
Study officials:
affiliation: Concentrics Research
name: Bill Miller, MD
role: STUDY_DIRECTOR
References: