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A Clinical Trial to Evaluate Efficacy and Safety of a Water-soluble Head Lice Product.

NCT03617926 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-07-05

Study results available
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Summary

The present study is set-up to compare in vivo clinical performance and safety of the test product versus an in the US commercially available, pyrethrum-based product (RID® shampoo).

Conditions

  • Head Lice
  • Pediculosis Capitis

Interventions

DEVICE

X92001666

the X92001666 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

RID shampoo

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.

Sponsors & Collaborators

  • Oystershell NV

    lead INDUSTRY

Principal Investigators

  • Elisabeth Rivera, CPI · Study PI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-07
Primary Completion
2018-06-30
Completion
2018-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03617926 on ClinicalTrials.gov