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
  Purpose

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 Intervention
Head Lice
Other: 4% dimethicone foam
Other: 1% permethrin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Oystershell NV:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 31
Study Start Date: September 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   4 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00672971

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

No publications provided

Responsible Party: Bart Rossel, Managing Director, Oystershell NV
ClinicalTrials.gov Identifier: NCT00672971     History of Changes
Other Study ID Numbers: OYS001-07
Study First Received: May 2, 2008
Last Updated: May 5, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 31, 2014