NCT07391059

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Perrigo CSCI · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not 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 shampoo for lice infestation treatment compared to a comparator device, already in market.

Conditions

• Headlice

Interventions

Type	Name	Description
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 ®

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2026-02-05
• Last updated: 2026-02-10

Locations

1 site across 1 country: Mauritius