A Study to Evaluate the Safety and Efficacy of Product X92001327 vs RID Shampoo in Subjects With Head Lice

Completed · Not applicable · Has a placebo group

Conditions studied: Head Lice

In brief

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.

Key facts

Study ID

NCT01803581

Run by

Oystershell NV

People needed

60

Starts

2013-03-05

Expected to finish

2013-08-12

Last updated by the study team

2018-04-05

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Lice Source services Inc — Plantation, Florida, United States

Full record on ClinicalTrials.gov

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