Status:

COMPLETED

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

Lead Sponsor:

Oystershell NV

Conditions:

Head Lice

Eligibility:

All Genders

4-85 years

Phase:

NA

Brief Summary

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.

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2007

Estimated Enrollment :

31 Patients enrolled

Trial Details

Trial ID

NCT00672971

Start Date

September 1 2007

End Date

November 1 2007

Last Update

May 6 2008

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Lice Source Services Inc

Plantation, Florida, United States, 33313