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

Head Lice Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00857935
• Other study ID #: SPN-203-07
• Secondary ID: Concentrics 7100
• Status: Completed
• Phase: Phase 2
• First received: March 5, 2009
• Last updated: March 6, 2009
• Start date: March 2007
• Est. completion date: April 2007

Study information

• Verified date: March 2009
• Source: ParaPRO LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A pilot study to compare the safety and efficacy of NatrOVA Creme Rinse 1% to NIX Creme Rinse in subjects with Pediculosis Capitis

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head Lice
• Lice Infestations
• Pediculosis Capitis

Intervention

Drug:
• NatrOVA Creme Rinse - 1%
NatrOVA Creme Rinse, one or two, 10-minute topical treatments (7 days apart)
• NIX Creme Rinse - 1% permethrin
NIX Creme Rinse: one or two, 10-minute topical treatments (7 days apart)

Locations

Country	Name	City	State
United States	Concentrics Research	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
ParaPRO LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes