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

Oystershell

Status: Completed

Conditions: Head Lice

Treatments: Other: X92001327; Other: RID shampoo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01803581

OYS004-0013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

X92001327

Experimental group

Description:

the X92001327 product is a lotion to be applied on dry hair for 15 minutes and then washed out using shampoo. The product is to be applied on Day 0 and repeated again on Day 7.

Treatment:

Other: X92001327

RID shampoo

Active Comparator group

Description:

The RID shampoo is to be applied on dry the hair for 10 minutes and then rinsed out with water. the product is to be applied on Day 0 and repeated again on Day 7.

Treatment:

Other: RID shampoo