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

Sponsor:	Oystershell NV
Information provided by:	Oystershell NV
ClinicalTrials.gov Identifier:	NCT00672971

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:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

Drug Information available for: Permethrin Dimethicone

U.S. FDA Resources

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
1: Experimental 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.
2: Active Comparator 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.

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

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

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Permethrin
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 09, 2009