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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00672971
Recruitment Status : Completed
First Posted : May 6, 2008
Last Update Posted : May 6, 2008
Information provided by:
Oystershell NV

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.

Condition or disease Intervention/treatment Phase
Head Lice Other: 4% dimethicone foam Other: 1% permethrin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Randomized Study to Compare the Safety and Efficacy of Silcap Plus (Approximately 4% Dimeticone) Against Nix Cream Rinse.
Study Start Date : September 2007
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Permethrin

Arm Intervention/treatment
Experimental: 1
4% dimethicone foam
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

Active Comparator: 2
1% permethrin
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Any adverse events during or after application of the product [ Time Frame: up to 7 or 8 d after product application ]

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00672971

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United States, Florida
Lice Source Services Inc
Plantation, Florida, United States, 33313
Sponsors and Collaborators
Oystershell NV
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Principal Investigator: Lidia Serrano, CRI Lice Source Services

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Responsible Party: Bart Rossel, Managing Director, Oystershell NV Identifier: NCT00672971     History of Changes
Other Study ID Numbers: OYS001-07
First Posted: May 6, 2008    Key Record Dates
Last Update Posted: May 6, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
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Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action