Head Lice, Pediculosis Capitis
Conditions
Keywords
Pediculosis Capitis, Head Lice
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.
Interventions
NatrOVA Creme Rinse, one or two, 10-minute topical treatments (7 days apart)
DRUGNIX Creme Rinse - 1% permethrin
NIX Creme Rinse: one or two, 10-minute topical treatments (7 days apart)
Sponsors
ParaPRO LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 14 days after last treatment |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 14 days after last treatment |
Countries
United States
Outcome results
None listed