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Completed

NCT Number: NCT01803581

A 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.

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Key information

Conditions

Head Lice

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lice Source services Inc

Plantation, Florida, 33313, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

X92001327

Other

RID shampoo

Other

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Oystershell NV

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 4, 2013
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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