Safety and Efficacy Study to Compare a 4% Dimethicone Foam and Nix Cream Rinse (1% Permethrin) in the Control of Head Lice
Information source: Oystershell NV
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Head Lice
Intervention: 4% dimethicone foam (Other); 1% permethrin (Other)
Phase: N/A
Status: Completed
Sponsored by: Oystershell NV Official(s) and/or principal investigator(s):
Lidia Serrano, CRI, Principal Investigator, Affiliation: Lice Source Services
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.
Clinical Details
Official title: An Open Label Randomized Study to Compare the Safety and Efficacy of Silcap Plus (Approximately 4% Dimeticone) Against Nix Cream Rinse.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Cure rate at the final visit (Day 14 or 15). Cure rate was defined as the number of subjects free of live head lice divided by the total number of subjects in the treatment group (x 100).
Secondary outcome: Any adverse events during or after application of the product
Eligibility
Minimum age: 4 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Lice Source Services Inc, Plantation, Florida 33313, United States
Additional Information
Starting date: September 2007
Last updated: May 5, 2008
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