Safety and Efficacy Study to Compare a 4% Dimethicone Foam and Nix Cream Rinse (1% Permethrin) in the Control of Head Lice

An Open Label Randomized Study to Compare the Safety and Efficacy of Silcap Plus (Approximately 4% Dimeticone) Against Nix Cream Rinse.

The purpose of this study was to evaluate the efficacy of a dimethicone foam in the control of head lice and to compare the efficacy to a permethrin based product.

Inclusion Criteria:

• 4 - 85 years of age
• active head lice infestation of at least ≥ 10 live lice
• short hair (hair no longer than 2 inches below the neck) or long hair (hair 2 inches below the neck to mid back)

Exclusion Criteria:

• had received or used an investigational new drug within the 30 days immediately preceding the study
• used any form of head lice treatment whether prescription, over-the-counter, or a home remedy for at least fourteen days prior to their study visit
• used topical medication of any kind on the hair for a period of 48 hours prior to the visit
• had a history of allergy to rag weed, permethrin, or mineral oil, or had taken trimethoprim or cotrimoxazole at evaluation or during the previous four weeks
• Female subjects that were pregnant or breast feeding