A Randomized, Controlled, Investigator-blinded, Comparative Study to Evaluate the Safety and Efficacy of Product X92001327 vs RID Shampoo in Subjects With Head Lice

Oystershell NV1 site in 1 country60 target enrollmentMarch 5, 2013

ConditionsHead Lice

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Head Lice
Sponsor: Oystershell NV
Enrollment: 60
Locations: 1
Primary Endpoint: The proportion of subjects lice free at the end of the study (Day 10)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare the efficacy and safety of an insecticide-free head lice product with that of a pyrethrum-based product.

Detailed Description

The primary objective of the study was to compare the safety and efficacy of X92001327 versus RID in subjects with head lice. The subjects received a single application on Day 0 of either X92001327 or RID shampoo based on the randomization schedule. A repeat application of the test product was administered on Day 7. Subjects visited the clinic four times: on Day 0, Day 1, Day 7 and Day 10.

Registry

clinicaltrials.gov

Start Date

March 5, 2013

End Date

August 12, 2013

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Oystershell NV

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female over the age of 1 at the time of signing the informed consent or giving assent
•Have an active head lice infestation of at least 5 live lice and 5 viable nits
•subject must be capable of understanding and providing written informed consent
•agree not to use any other pediculicides or medicated hair grooming products for the duration of the study
•agree not to use a lice comb during the study
•the parent or guardian of a child must be willing to have other family members screened for head lice.
•have a single place of residence

Exclusion Criteria

•used any form of head lice treatment whether prescription or over the counter or home remedy at least four weeks prior to their screening visit
•used any topical medication of any kind for a period of 48 hours prior to the screening visit
•individuals on systemic or topical drugs or medications, including systemic antibiotics, which in the opinion of the investigative personnel may interfere with the study results
•has a history of allergy or hypersensitivity to ragweed, hydrocarbons, sesame oil, perfume or any ingredient in either test product
•individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigative personnel will interfere with the evaluation of the test product
•individuals who, in the opinion of the investigative personnel do not understand the subject requirements for study participation and/or may be likely to exhibit poor compliance with the required visits
•females who are pregnant or nursing
•patients that have taken trimethoprim or a combination of sulfamethoxazole at evaluation or during the previous 4 weeks
•subjects with hair longer than mid back

Outcomes

Primary Outcomes

The proportion of subjects lice free at the end of the study (Day 10)

Time Frame: Day 10

Primary objective of this study was the cure rate (%) in each treatment group, following two applications (day 0 and day 7) of the specific test product, as assessed on the last evaluation visit (day 10).