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

This study has been completed.
Sponsor:
Information provided by:
Oystershell NV
ClinicalTrials.gov Identifier:
NCT00672971
First received: May 2, 2008
Last updated: May 5, 2008
Last verified: May 2008

May 2, 2008
May 5, 2008
September 2007
November 2007   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00672971 on ClinicalTrials.gov Archive Site
Any adverse events during or after application of the product [ Time Frame: up to 7 or 8 d after product application ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study to Compare a 4% Dimethicone Foam and Nix Cream Rinse (1% Permethrin) in the Control of Head Lice
An Open Label Randomized Study to Compare the Safety and Efficacy of Silcap Plus (Approximately 4% Dimeticone) Against Nix Cream Rinse.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Head Lice
  • 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
  • Experimental: 1
    4% dimethicone foam
    Intervention: Other: 4% dimethicone foam
  • Active Comparator: 2
    1% permethrin
    Intervention: Other: 1% permethrin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
November 2007
November 2007   (final data collection date for primary outcome measure)

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
Both
4 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00672971
OYS001-07
No
Bart Rossel, Managing Director, Oystershell NV
Oystershell NV
Not Provided
Principal Investigator: Lidia Serrano, CRI Lice Source Services
Oystershell NV
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP