Status:
COMPLETED
A Bioequivalence Study, Comparing Two Formulations of Ivermectin Lotion, 0.5%
Lead Sponsor:
Sun Pharmaceutical Industries, Inc.
Conditions:
Lice; Head Lice
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2017
Estimated Enrollment :
413 Patients enrolled
Trial Details
Trial ID
NCT03257943
Start Date
March 20 2017
End Date
August 18 2017
Last Update
May 18 2018
Active Locations (1)
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1
Taro Pharmaceuticals USA Inc.
Hawthorne, New York, United States, 10532