Conditions: Head Lice
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 239
Healthy volunteers: yes

Brief summary:
To establish the therapeutic equivalence and safety of a generic Benzyl Alcohol Lotion 5% with Ulesfia Lotion 5% in eradication of head lice in the study subjects.

Detailed description:

Arms:
arm 1: Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out. arm 2: Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out. arm 3: Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.

Interventions: intervention 1: Benzyl Alcohol Lotion 5% intervention 2: Ulesfia (benzyl alcohol lotion) 5% intervention 3: Placebo
Intervention descriptions: intervention 1: White topical lotion intervention 2: White topical lotion intervention 3: White topical lotion

Protocol document: