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

Tracking Information
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; (submitted: May 5, 2008)	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; (submitted: May 5, 2008)	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
Condition ICMJE	Head Lice
Intervention ICMJE	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
Study Arms	Experimental: 1 4% dimethicone foam Intervention: Other: 4% dimethicone foam; Active Comparator: 2 1% permethrin Intervention: Other: 1% permethrin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 5, 2008)	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: 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
Sex/Gender	Sexes Eligible for Study: All
Ages	4 Years to 85 Years (Child, Adult, Older Adult)
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	Principal Investigator: Lidia Serrano, CRI Lice Source Services
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