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

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ClinicalTrials.gov Identifier: NCT01803581
Recruitment Status : Completed
First Posted : March 4, 2013
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Oystershell NV

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.

Condition or disease Intervention/treatment Phase
Head Lice Other: X92001327 Other: RID shampoo Not Applicable

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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Actual Study Start Date : March 5, 2013
Actual Primary Completion Date : June 20, 2013
Actual Study Completion Date : August 12, 2013

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



Primary Outcome Measures :
  1. The proportion of subjects lice free at the end of the study (Day 10) [ Time Frame: 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).


Secondary Outcome Measures :
  1. The proportion of subjects lice free at each of the intermediate evaluations (Day 1, Day 7) [ Time Frame: 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).


Other Outcome Measures:
  1. Eye irritation [ Time Frame: Day0, Day 1, Day7, Day10 ]
    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.

  2. Scalp condition [ Time Frame: Day0, Day1, Day7, Day10 ]
    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.

  3. Adverse events collection [ Time Frame: Day 0, Day1, Day7, Day10 ]
    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.



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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Oystershell NV
ClinicalTrials.gov Identifier: NCT01803581     History of Changes
Other Study ID Numbers: OYS004-0013
First Posted: March 4, 2013    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: November 2013

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