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

Head Lice Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01803581
• Other study ID #: OYS004-0013
• Status: Completed
• Phase: N/A
• First received: February 12, 2013
• Last updated: April 3, 2018
• Start date: March 5, 2013
• Est. completion date: August 12, 2013

Study information

• Verified date: November 2013
• Source: Oystershell NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 12, 2013
• Est. primary completion date: June 20, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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

Related Conditions & MeSH terms

• Head Lice
• Lice Infestations

Intervention

Other:
• X92001327

• RID shampoo

Locations

Country	Name	City	State
United States	Lice Source services Inc	Plantation	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Oystershell NV

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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