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

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.

• Other: 4% dimethicone foam
  The dimethicone foam is applied to dry hair and left on the hair for approximately 15 minutes. The product is then removed by washing the hair with baby shampoo. The foam is applied two time, separated by an interval of 7-9 days.
  Other Name: Oxykal, Neo-paraderma
• Other: 1% permethrin
  Nix® Cream Rinse is applied as indicated on the product labeling. The cream rinse is applied to wet hair and left on the hair for 10 minutes. The hair is then rinsed with tepid water to remove the product, toweled dry, and combed with a detangling comb. The product is applied two times, separated by an interval of 7-9 days.
  Other Name: Nix cream rinse

• Experimental: 1
  4% dimethicone foam
  Intervention: Other: 4% dimethicone foam
• Active Comparator: 2
  1% permethrin
  Intervention: Other: 1% permethrin

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