A Safety and Efficacy Pilot Study Comparing NatrOVA Creme Rinse 1% and NIX Creme Rinse

NCT00857935 | Completed Phase 2

• 2 other identifiers: SPN-203-07Concentrics 71007
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Pediculosis Capitis; Head Lice

Keywords

Pediculosis Capitis; Head Lice

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

NatrOVA Creme Rinse - 1%

Drug: NatrOVA Creme Rinse - 1%

2

ACTIVE COMPARATOR

NIX Creme Rinse

Drug: NIX Creme Rinse - 1% permethrin

Interventions

NatrOVA Creme Rinse - 1% DRUG

NatrOVA Creme Rinse, one or two, 10-minute topical treatments (7 days apart)

1

NIX Creme Rinse - 1% permethrin DRUG

NIX Creme Rinse: one or two, 10-minute topical treatments (7 days apart)

2

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ParaPRO LLC: lead

Study Sites (1)

Concentrics Research

Indianapolis, Indiana, 46240, United States

Location

MeSH Terms

Interventions

Permethrin

Intervention Hierarchy (Ancestors)

Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pyrethrins; Cyclopentane Monoterpenes; Monoterpenes; Terpenes

Study Officials

• Mark Moore, MD

  Concentrics Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 9, 2009
• Study Start: March 1, 2007
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: March 9, 2009

Record last verified: 2009-03

Locations

US (1)