Clinical trial NCT00857935: A Safety and Efficacy Pilot Study Comparing NatrOVA Creme Rinse 1% and NIX Creme Rinse
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pediculosis Capitis
Head Lice
Keywords: Pediculosis Capitis
Head Lice
Lead sponsor: ParaPRO LLC
Sponsor class: INDUSTRY
First posted: 2009-03-09
Enrollment: 24
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 pilot study to compare the safety and efficacy of NatrOVA Creme Rinse 1% to NIX Creme Rinse in subjects with Pediculosis Capitis

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 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

Primary outcomes:
measure: 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.
timeFrame: 14 days after last treatment
Secondary outcomes:
measure: 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.
timeFrame: 14 days after last treatment
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Concentrics Research
state: Indiana
Study officials:
affiliation: Concentrics Research
name: Mark Moore, MD
role: PRINCIPAL_INVESTIGATOR
References: