Conditions: Pediculosis
Keywords: Head Lice
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 254
Healthy volunteers: no

Brief summary:
In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an established head lice treatment. The new formulation has been evaluated in 2 previous studies of patients 2 years of age and older.

Detailed description:
This is a Phase III, multi-center, investigator-blinded, two-arm, randomized, parallel group study, evaluating the safety and efficacy of a Malathion Gel, 0.5% formulation, manufactured by Taro. The objective is to show superiority of the novel product to an active control, Nix® Crème Rinse, manufactured by Insight Pharmaceuticals.

Arms:
arm 1: Malathion gel 0.5% 30 minute application arm 2: Nix applied to scalp for 10 minutes

Interventions: intervention 1: Malathion gel 0.5% intervention 2: Permethrin 1% rinse
Intervention descriptions: intervention 1: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present. intervention 2: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present.

Protocol document: