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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


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
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