A Bioequivalence Study, Comparing Two Formulations of Ivermectin Lotion, 0.5%

Phase 1

Completed

• Conditions: Lice; Head Lice
• Interventions: Drug: Vehicle of the Test product; Drug: Ivermectin Lotion, 0.5%; Drug: SKLICE (ivermectin) Lotion, 0.5%

• Registration Number: NCT03257943
• Lead Sponsor: Taro Pharmaceuticals USA

Brief Summary

A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing Ivermectin Lotion, 0.5%

Detailed Description

A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing Ivermectin Lotion, 0.5% to Sklice (Ivermectin) Lotion, 0.5% and both active treatment to a placebo control in the treatment of subjects with active infestation with head lice and their Ova

Study Timeline

• Study Start: 2017-03-20
• Study First Submitted: 2017-05-03
• Primary Completion: 2017-06-27
• Study Completion: 2017-08-18
• Study First Submitted QC: 2017-08-18
• Study First Posted: 2017-08-22
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-16
• Last Update Posted: 2018-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 413

Inclusion Criteria

• Subjects 18 years of age or older must have provided IRB-approved written informed consent and sign a HIPAA authorization.
• Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.

Exclusion Criteria

• Subjects with a history of hypersensitivity or allergy to or any component of the study product.
• Subject with history of irritation or sensitivity to pediculicides or hair care products.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle of the Test product	Vehicle of the Test product	One 10 minute application, under at-home use conditions
Ivermectin Lotion, 0.5%	Ivermectin Lotion, 0.5%	One 10 minute application, under at-home use conditions
SKLICE (ivermectin) Lotion, 0.5%	SKLICE (ivermectin) Lotion, 0.5%	One 10 minute application, under at-home use conditions

Primary Outcome Measures

Name	Time	Method
Demonstration of Bioequivalence in proportion of index subjects who are lice free	Day 15 (14 days after application of study treatment)	Demonstration of Bioequivalence in proportion of index subjects who are lice free

Trial Locations

Locations (1)

Taro Pharmaceuticals USA Inc.; 🇺🇸 Hawthorne, New York, United States