Conditions: Pediculus Humanus Capitis Head Lice
Keywords: Head Lice Lice Infestation Pediculosis Pediculosis Capitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 230
Healthy volunteers: no

Brief summary:
The main purpose of this study is to investigate the safety and efficacy of an investigational treatment for head lice infestation against a placebo.

Detailed description:
The main purpose of this study is to investigate the safety and efficacy of an investigational treatment for head lice infestation against a placebo.

Arms:
arm 1: Subjects are treated either once (day1) or twice (day 1 and 7) with either placebo or 2.5% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair. arm 2: Subjects are treated either once (day1) or twice (day 1 and 7) with either placebo or 10% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair. arm 3: Subjects are treated either once (day1) or twice (day 1 and 7) with either placebo or 12.5% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair. arm 4: None

Interventions: intervention 1: Placebo intervention 2: BGC20-0582
Intervention descriptions: intervention 1: Vehicle Only intervention 2: BGC20-0582 is a topical gel formulation of a naturally derived product. Subjects are treated either once (day 1) or twice (day 1 and 7) with either placebo or BGC20-0582 at one of the three concentrations. Following application of the BGC20-0582 lice treatment gel of placebo the product is rinsed from the subjects hair.

Protocol document: