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

Tracking Information

First Received Date ^ICMJE

May 2, 2008

Last Updated Date

May 5, 2008

Start Date ^ICMJE

September 2007

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00672971 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

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

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Head Lice

Intervention ^ICMJE

Other: 4% dimethicone foam
Other: 1% permethrin

Study Arms / Comparison Groups

Experimental: 4% dimethicone foam
Active Comparator: 1% permethrin

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2007

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

Gender

Both

Ages

4 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00672971

Responsible Party

Bart Rossel, Managing Director, Oystershell NV

Study ID Numbers ^ICMJE

OYS001-07

Study Sponsor ^ICMJE

Oystershell NV

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Lidia Serrano, CRI

Lice Source Services

Information Provided By

Oystershell NV

Verification Date

May 2008

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