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NOT YET RECRUITING
NCT07391059
NA

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

Sponsor: Perrigo CSCI

View on ClinicalTrials.gov

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.

Official title: Randomized Medical Device Class IIa Clinical Investigation to Assess the Safety and Efficacy of a New Shampoo for Head Lice Treatment

Key Details

Gender

All

Age Range

2 Years - Any

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2026-02

Completion Date

2026-05

Last Updated

2026-02-10

Healthy Volunteers

No

Conditions

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 ®

Locations (1)

CIDP

Phoenix, Mauritius