NCT03617926

A Clinical Trial to Evaluate Efficacy and Safety of a Water-soluble Head Lice Product.

A Randomized, Controlled, Investigator-Assessor Blinded, Comparative Study to Evaluate the Safety and Efficacy of a Water-Soluble Head Lice Suffocation Product (X92001666) vs RID Shampoo (Pyrethrin) in Subjects With Head Lice

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Oystershell NV · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

Summary

The present study is set-up to compare in vivo clinical performance and safety of the test product versus an in the US commercially available, pyrethrum-based product (RID® shampoo).

Detailed description

The present study is set-up to compare in vivo clinical performance and safety of the test product versus an in the US commercially available, pyrethrum-based product (RID® shampoo). The study will be performed in subjects ≥2 year of both genders with confirmed diagnosis of head lice infestation. 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	X92001666	the X92001666 product is a lotion to be applied on dry hair for 15 minutes and then washed out using shampoo. The product is to be applied on Day 0 and repeated again on Day 7.
OTHER	RID shampoo	Active Comparator: RID shampoo The RID shampoo is to be applied on dry the hair for 10 minutes and then rinsed out with water. the product is to be applied on Day 0 and repeated again on Day 7.

Timeline

• Start date: 2018-03-07
• Primary completion: 2018-06-30
• Completion: 2018-06-30
• First posted: 2018-08-07
• Last updated: 2022-07-05
• Results posted: 2022-06-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study