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

NCT07391059 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-02-10

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 shampoo for lice infestation treatment compared to a comparator device, already in market.

Conditions

  • Headlice

Interventions

OTHER

INVESTIGATIONAL DEVICE, Paranix ® shampoo 2 minutes

New medical device shampoo for the treatment of head lice infestation: Paranix ® with 2 minute application time

OTHER

INVESTIGATIONAL DEVICE, Paranix ® shampoo 5 minutes

New medical device shampoo for the treatment of head lice infestation: Paranix ®, with 5 minutes application time

OTHER

COMPARATOR DEVICE, Pouxit ®

well established medical device shampoo for the treatment of head lice infestation - Pouxit ®

Sponsors & Collaborators

  • Perrigo CSCI

    lead INDUSTRY

Principal Investigators

  • Gitanjali PETKAR, Dermatologist

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2026-05-31
Completion
2026-05-31

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 NCT07391059 on ClinicalTrials.gov