Conditions: Pediculosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 142
Healthy volunteers: no

Brief summary:
Phase 2 study to assess the safety and effectiveness of a product to treat children and adults with head lice

Detailed description:

Arms:
arm 1: Group A Low-Dose Ha44 Gel 0.37% w/w topically administered to head and scalp.Single application for 10 minutes. arm 2: Group B High-Dose Ha44 Gel 0.74% w/w. Topically administered to hair and scalp. Single application for 10 minutes of duration. arm 3: Group C Placebo/ vehicle Ha44 Gel. Topically administered to hair and scalp.Single application for 10 minutes of duration.

Interventions: intervention 1: Group A - Low-Dose Ha44 0.37% w/w intervention 2: Group B - High Dose Ha44 Gel 0.74% w/w intervention 3: Group C - Placebo
Intervention descriptions: intervention 1: Low Dose Ha44 Gel applied to scalp and hair for 10 minutes intervention 2: High Dose Ha44 Gel applied to scalp and hair for 10 minutes intervention 3: Placebo- vehicle Ha44 Gel without active ingredient applied to scalp and hair for 10 minutes

Protocol document: