NCT02997904

A Clinical Trial Evaluating the Efficacy of Resultz Lice and Egg Elimination Kit on Pediatric and Adult Subjects

A Randomized Sham Controlled Double Blinded Single Site Clinical Trial Evaluating the Efficacy of Resultz Lice and Egg Elimination Kit for the Removal of Human Head Lice and Eggs on Pediatric and Adult Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Piedmont Pharmaceuticals, LLC · Industry
• Sex: All
• Age: 2 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

A one day study to demonstrate that Resultz Lice and Egg Elimination Kit is statistically superior to a sham control with one hour of combing.

Detailed description

Resultz Lice and Egg Elimination Kit will be efficacious in the removal of human head lice infestations in children and adult subjects under simulated real world conditions.

Conditions

• Pediculus Capitis

Interventions

Type	Name	Description
DEVICE	Apply Liquid Then Comb Out	Apply liquid to dry hair, wait for 5 minutes, then comb out lice and eggs for up to one hour

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-01-01
• Completion: 2017-02-01
• First posted: 2016-12-20
• Last updated: 2017-08-31
• Results posted: 2017-08-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study