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A Clinical Trial to Evaluate Efficacy and Safety of a New Suffocating Head Lice Product.

NCT05378477 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2022-09-21

No results posted yet for this study

Summary

The present study is set-up to compare in vivo clinical performance and safety of the test product (X92001752) versus 3 other pediculicides (2 medical devices and 1 conventional pesticide).

Conditions

  • Head Lice
  • Pediculosis Capitis

Interventions

DEVICE

X92001752

The test product is a lotion to be applied on dry hair for 10 minutes and then washed out using shampoo. The product is to be applied on Day 0 and repeated again on Day 7.

DEVICE

RID Super Max Solution

RID Super Max Solution is a lotion to be applied on dry hair for 10 minutes and then washed out using shampoo. The product is to be applied on Day 0 and repeated again on Day 7.

DRUG

Nix Crème

Nix crème must be applied on dry hair for 10 minutes and then washed out with water. The product is to be applied on Day 0 and repeated again on Day 7.

DEVICE

Pouxit Végétal

Pouxit Végétal must be applied on dry hair for 30 minutes and then washed out using shampoo. According to the instructions for use, only 1 treatment must be performed.

Sponsors & Collaborators

  • Oystershell NV

    lead INDUSTRY

Principal Investigators

  • Susel Gonzalez Acosta, ARNP · PI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-17
Primary Completion
2022-09-30
Completion
2022-09-30
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 NCT05378477 on ClinicalTrials.gov