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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1
Lice Source Services Inc
Plantation, Florida, United States, 33313