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

Lice; Head Lice Clinical Trial

Official title:

A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-group Study, Comparing Ivermectin Lotion, 0.5% in the Treatment of Subjects With Active Infestation With Head Lice and Their Ova

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03257943
• Other study ID #: IVRL 1604
• Status: Completed
• Phase: Phase 1
• Start date: March 20, 2017
• Est. completion date: August 18, 2017

Study information

• Verified date: May 2018
• Source: Taro Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 413
• Est. completion date: August 18, 2017
• Est. primary completion date: June 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lice; Head Lice

Intervention

Drug:
• Ivermectin Lotion, 0.5%
Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.)
• SKLICE (ivermectin) Lotion, 0.5%
SKLICE (ivermectin) Lotion, 0.5% (Arbor Pharmaceuticals, LLC)
• Vehicle of the Test product
Vehicle for Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.)

Locations

Country	Name	City	State
United States	Taro Pharmaceuticals USA Inc.	Hawthorne	New York

Sponsors (1)

Lead Sponsor	Collaborator
Taro Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstration of Bioequivalence in proportion of index subjects who are lice free	Demonstration of Bioequivalence in proportion of index subjects who are lice free	Day 15 (14 days after application of study treatment)