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

Head Lice Clinical Trial

Official title:
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.

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05378477
Study type Interventional
Source Oystershell NV
Contact Elisabeth Rivera, CRD
Phone 305-387-0051
Email sffelisabeth@sffhrc.com
Status Recruiting
Phase N/A
Start date January 17, 2022
Completion date September 30, 2022
View Details
See also
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Completed NCT03617926 - A Clinical Trial to Evaluate Efficacy and Safety of a Water-soluble Head Lice Product. N/A
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Completed NCT01066585 - A Safety and Efficacy Study Comparing 0.5% Ivermectin Cream to a Vehicle Control in Subjects With Head Lice Infestation Phase 3
Completed NCT00857935 - A Safety and Efficacy Pilot Study Comparing NatrOVA Creme Rinse 1% and NIX Creme Rinse Phase 2
Completed NCT00301340 - Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice Phase 3
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