NCT05378477

A Clinical Trial to Evaluate Efficacy and Safety of a New Suffocating Head Lice Product.

Randomized, Controlled, Assessor-Blinded, Comparative Study to Evaluate Safety & Efficacy of a New Suffocation Product vs an Oligodecene-based Suffocation Product, 1% Permethrin & a Fatty Acids-based Product in Subjects With Head Lice.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Oystershell NV · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Accepted

Summary

The present study is set-up to compare in vivo clinical performance and safety of the test product (X92001752) versus 3 other pediculicides (2 medical devices and 1 conventional pesticide).

Detailed description

The present study is set-up to compare in vivo clinical performance and safety of the test product versus a) RID Super Max Solution (oligodecene oil), Nix crème (1% permethrin), and Pouxit Végétal (fatty acid salts). 220 subjects (n=55 per treatment group) with confirmed diagnosis of head lice infestation will be included. To support safety, local and global tolerability, skin and ocular irritation will be assessed and adverse events (AEs) will be registered.

Conditions

• Head Lice
• Pediculosis Capitis

Interventions

Type	Name	Description
DEVICE	X92001752	The test product is a lotion to be applied on dry hair for 10 minutes and then washed out using shampoo. The product is to be applied on Day 0 and repeated again on Day 7.
DEVICE	RID Super Max Solution	RID Super Max Solution is a lotion to be applied on dry hair for 10 minutes and then washed out using shampoo. The product is to be applied on Day 0 and repeated again on Day 7.
DRUG	Nix Crème	Nix crème must be applied on dry hair for 10 minutes and then washed out with water. The product is to be applied on Day 0 and repeated again on Day 7.
DEVICE	Pouxit Végétal	Pouxit Végétal must be applied on dry hair for 30 minutes and then washed out using shampoo. According to the instructions for use, only 1 treatment must be performed.

Timeline

• Start date: 2022-01-17
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2022-05-18
• Last updated: 2022-09-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study