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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Oystershell NV
ClinicalTrials.gov Identifier:
NCT01803581
First received: February 12, 2013
Last updated: March 1, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Head Lice
Other: X92001327
Other: RID shampoo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Oystershell NV:

Primary Outcome Measures:
  • proportion of subjects lice free at the end of the study (Day 10) [ Time Frame: Day 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the proportion of subjects lice free at each of the intermediate evaluations (Day 1, Day 7) [ Time Frame: Day 1, Day 7 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • eye irritation [ Time Frame: Day1, Day7, Day10 ] [ Designated as safety issue: Yes ]
  • scalp condition [ Time Frame: Day0, Day1, Day7, Day10 ] [ Designated as safety issue: Yes ]
  • Adverse events collection [ Time Frame: Day1, Day7, Day10 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: February 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803581

Locations
United States, Florida
Lice Source services Inc
Plantation, Florida, United States, 33313
Sponsors and Collaborators
Oystershell NV
Investigators
Principal Investigator: Lidia Serrano Lice Source Services
  More Information

Publications:
Responsible Party: Oystershell NV
ClinicalTrials.gov Identifier: NCT01803581     History of Changes
Other Study ID Numbers: OYS004-0013
Study First Received: February 12, 2013
Last Updated: March 1, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lice Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on July 26, 2014