NCT05379114

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

Comparative, Monocentric Study for the Evaluation of the Non-inferiority of a New Medical Device on the Treatment of Head Lice Infestation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Perrigo CSCI · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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 ®

Timeline

• Start date: 2022-05-18
• Primary completion: 2022-07-01
• Completion: 2022-09-01
• First posted: 2022-05-18
• Last updated: 2022-06-01

Locations

1 site across 1 country: Mauritius