Clinical Endpoint Study of Ivermectin 0.5% Lotion

Status Completed

Clinical Trial Summary

This clinical study is designed to evaluate the clinical (therapeutic) effect of a generic ivermectin lotion 0.5% (Actavis Laboratories UT, Inc.) relative to that of the Food and Drug Administration (FDA) Reference Listed Drug (RLD) SKLICE® (ivermectin) lotion, 0.5% (Arbor Pharmaceuticals, LLC) in participants with active head lice infestation. Additionally, both the test and reference (that is; the RLD) treatments were tested for superiority to a placebo.

Clinical Trial Description

Participants will be randomized by household in a 3:3:1 ratio to receive generic ivermectin lotion 0.5%, Sklice (ivermectin) lotion 0.5%, or vehicle lotion. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03301649
Study type	Interventional
Source	Actavis Inc.
Contact
Status	Completed
Phase	Phase 3
Start date	October 7, 2017
Completion date	March 12, 2018

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00988533` - A Pharmacokinetics (PK) Study in Lice Infested Children 6 Months to 3 Years of Age	Phase 1
Completed	`NCT00672971` - Safety and Efficacy Study to Compare a 4% Dimethicone Foam and Nix Cream Rinse (1% Permethrin) in the Control of Head Lice	N/A
Completed	`NCT00858481` - A Pilot Dose Ranging Study of Spinosad Creme Rinse	Phase 2
Completed	`NCT00995124` - Trial of the Ovicidal Activity of Three Head Lice Products (NeutraLice Lotion®, NeutraLice Advance® and Moov Head Lice Solution®) After a Single Application	Phase 4
Completed	`NCT00994422` - Study Comparing the Safety and Efficacy of 0.5% Ivermectin Cream to Placebo in Lice Infested Subjects	Phase 2
Completed	`NCT03337490` - A Clinical Endpoint Bioequivalence Study to Assess Efficacy and Safety of Ivermectin 0.5% Lotion in the Treatment of Head Lice	Phase 3
Completed	`NCT06333054` - Safety and Efficacy of a Head Lice Shampoo	N/A
Completed	`NCT02213055` - Pediatric Head Lice Study Product Comparison	Phase 2
Completed	`NCT02974088` - Neem Lotion With Combing for Lice	Phase 2
Recruiting	`NCT05379114` - Comparative Study for the Evaluation of a New Medical Device on the Treatment of Head Lice Infestation	N/A
Completed	`NCT03617926` - A Clinical Trial to Evaluate Efficacy and Safety of a Water-soluble Head Lice Product.	N/A
Completed	`NCT01803581` - A Study to Evaluate the Safety and Efficacy of Product X92001327 vs RID Shampoo in Subjects With Head Lice	N/A
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	`NCT01068158` - A Study Comparing the Safety and Efficacy of 0.5% Ivermectin Cream to Placebo in Lice Infested Subjects	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
Completed	`NCT02061813` - Dermal Safety Study to Evaluate Potential Irritation of Abametapir Lotion	Phase 1
Completed	`NCT02062073` - Dermal Safety Study to Evaluate the Sensitizing Potential of Abametapir Lotion	Phase 1
Completed	`NCT00605956` - NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers	Phase 1
Completed	`NCT00301327` - Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice.	Phase 3