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

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

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

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

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.