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

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

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.

Study Overview

• Status: Completed
• Conditions: Head Lice
• Intervention / Treatment: Other: X92001327; Other: RID shampoo

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Plantation, Florida, United States, 33313
      • Lice Source services Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: X92001327; 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.	Other: X92001327
ACTIVE_COMPARATOR: RID shampoo; 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.	Other: RID shampoo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of subjects lice free at the end of the study (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).	Day 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of subjects lice free at each of the intermediate evaluations (Day 1, Day 7)	Secondary outcome involved the cure rate (%) in each treatment group, following one application of the specific test product, as assessed 24h post treatment (day 1) and on day 7 (prior to the second treatment).	Day 1, Day 7

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eye irritation	As part of the evaluation of the safety profile of both test products, eye irritation has been evaluated at day 0 (prior to and after first treatment), day 1 (24h after the first treatment), day 7 (prior to and after second treatment) and day 10, respectively.	Day0, Day 1, Day7, Day10
Scalp condition	As part of the evaluation of the safety profile of both test products, scalp condition has been evaluated at day 0 (prior to and after first treatment), day 1 (24h after the first treatment), day 7 (prior to and after second treatment) and day 10, respectively.	Day0, Day1, Day7, Day10
Adverse events collection	Adverse events have been collected from the initial application of test product until completion of the final follow-up visit (day 10). For any adverse event, date of onset, intensity, seriousness and causal relationship to the study treatment have been recorded.	Day 0, Day1, Day7, Day10

Collaborators and Investigators

• Sponsor: Oystershell NV
• Investigators: Principal Investigator: Lidia Serrano, Lice Source Services

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 5, 2013
• Primary Completion (ACTUAL): June 20, 2013
• Study Completion (ACTUAL): August 12, 2013

Study Registration Dates

• First Submitted: February 12, 2013
• First Submitted That Met QC Criteria: March 1, 2013
• First Posted (ESTIMATE): March 4, 2013

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 3, 2018
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Parasitic Diseases; Ectoparasitic Infestations; Skin Diseases, Parasitic; Skin Diseases, Infectious; Lice Infestations
• Other Study ID Numbers: OYS004-0013