Clinical trial NCT01803581: A Study to Evaluate the Safety and Efficacy of Product X92001327 vs RID Shampoo in Subjects With Head Lice
Official title: A Randomized, Controlled, Investigator-blinded, Comparative Study to Evaluate the Safety and Efficacy of Product X92001327 vs RID Shampoo in Subjects With Head Lice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head Lice
Lead sponsor: Oystershell NV
Sponsor class: INDUSTRY
First posted: 2013-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The proportion of subjects lice free at the end of the study (Day 10)
timeFrame: Day 10
Secondary outcomes:
measure: The proportion of subjects lice free at each of the intermediate evaluations (Day 1, Day 7)
timeFrame: Day 1, Day 7
Other outcomes:
measure: Eye irritation
timeFrame: Day0, Day 1, Day7, Day10
measure: Scalp condition
timeFrame: Day0, Day1, Day7, Day10
measure: Adverse events collection
timeFrame: Day 0, Day1, Day7, Day10
Locations:
city: Plantation
country: United States
facility: Lice Source services Inc
state: Florida
Study officials:
affiliation: Lice Source Services
name: Lidia Serrano
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barker SC, Burgess I, Meinking TL, Mumcuoglu KY. International guidelines for clinical trials with pediculicides. Int J Dermatol. 2012 Jul;51(7):853-8. doi: 10.1111/j.1365-4632.2011.05446.x.