Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of Product X92001327 vs RID Shampoo in Subjects With Head Lice
Lead Sponsor:
Oystershell NV
Conditions:
Head Lice
Eligibility:
All Genders
1+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 5 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01803581
Start Date
March 5 2013
End Date
August 12 2013
Last Update
April 5 2018
Active Locations (1)
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1
Lice Source services Inc
Plantation, Florida, United States, 33313