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Comparative Study for the Evaluation of a New Medical Device on the Treatment of Head Lice Infestation

NCT05379114 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2022-06-01

No results posted yet for this study

Summary

Pediculosis capitis or head lice infestation is a human medical condition caused by the infestation of the hair by the parasitic insect Pediculus humanus capitis (human head lice). The most common symptom of infestation is pruritus (itching) on the head which normally intensifies 3 to 4 weeks after the initial infestation.

The test item has been developed with the ambition to offer a complete head lice treatment, whilst also offering ultimate convenience in use - making treatment of head lice infestation easy, and effective in few minutes.

The objectives of this clinical study are to assess the efficacy and the safety of a new Medical Device for lice infestation treatment compared to a comparator device, already in market.

Conditions

  • Head Lice

Interventions

OTHER

INVESTIGATIONAL DEVICE

new medical device for the treatment of head lice infestation: Paranix ®

OTHER

Comparator device

well established medical device for the treatment of head lice infestation (dimethicone based) - Pouxit ®

Sponsors & Collaborators

  • Perrigo CSCI

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-18
Primary Completion
2022-07-31
Completion
2022-09-30

Countries

  • Mauritius

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 NCT05379114 on ClinicalTrials.gov