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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

NCT ID: NCT00672971

Last Updated: 2008-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2007-11-30

Brief Summary

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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

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Conditions

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Head Lice

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

4% dimethicone foam

Group Type EXPERIMENTAL

4% dimethicone foam

Intervention Type OTHER

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

1% permethrin

Group Type ACTIVE_COMPARATOR

1% permethrin

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Oxykal, Neo-paraderma Nix cream rinse

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oystershell NV

INDUSTRY

Sponsor Role lead

Responsible Party

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Oystershell NV

Principal Investigators

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Lidia Serrano, CRI

Role: PRINCIPAL_INVESTIGATOR

Lice Source Services

Locations

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Lice Source Services Inc

Plantation, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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OYS001-07

Identifier Type: -

Identifier Source: org_study_id