Safety and Efficacy Study to Compare a 4% Dimethicone Foam and Nix Cream Rinse (1% Permethrin) in the Control of Head Lice
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ClinicalTrials.gov Identifier: NCT00672971 |
Recruitment Status
:
Completed
First Posted
: May 6, 2008
Last Update Posted
: May 6, 2008
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Sponsor:
Oystershell NV
Information provided by:
Oystershell NV
Tracking Information | ||||
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First Submitted Date ICMJE | May 2, 2008 | |||
First Posted Date ICMJE | May 6, 2008 | |||
Last Update Posted Date | May 6, 2008 | |||
Study Start Date ICMJE | September 2007 | |||
Actual Primary Completion Date | November 2007 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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). [ Time Frame: 14 or 15 days after 1st treatment ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE |
Any adverse events during or after application of the product [ Time Frame: up to 7 or 8 d after product application ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Safety and Efficacy Study to Compare a 4% Dimethicone Foam and Nix Cream Rinse (1% Permethrin) in the Control of Head Lice | |||
Official Title ICMJE | An Open Label Randomized Study to Compare the Safety and Efficacy of Silcap Plus (Approximately 4% Dimeticone) Against Nix Cream Rinse. | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Head Lice | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
31 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | November 2007 | |||
Actual Primary Completion Date | November 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 4 Years to 85 Years (Child, Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00672971 | |||
Other Study ID Numbers ICMJE | OYS001-07 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Bart Rossel, Managing Director, Oystershell NV | |||
Study Sponsor ICMJE | Oystershell NV | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Oystershell NV | |||
Verification Date | May 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |