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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

Primary Purpose

Head Lice

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

4% dimethicone foam

1% permethrin

About this trial

This is an interventional treatment trial for Head Lice

Eligibility Criteria

4 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Lice Source Services Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

4% dimethicone foam

1% permethrin

Outcomes

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).

Secondary Outcome Measures

Any adverse events during or after application of the product

Full Information

NCT ID

NCT00672971

First Posted

May 2, 2008

Last Updated

May 5, 2008

Sponsor

Oystershell NV

1. Study Identification

Unique Protocol Identification Number

NCT00672971

Brief Title

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

Official Title

An Open Label Randomized Study to Compare the Safety and Efficacy of Silcap Plus (Approximately 4% Dimeticone) Against Nix Cream Rinse.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

November 2007 (Actual)

Study Completion Date

November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Oystershell NV

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head Lice

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

4% dimethicone foam

Arm Title

Arm Type

Active Comparator

Arm Description

1% permethrin

Intervention Type

Other

Intervention Name(s)

4% dimethicone foam

Other Intervention Name(s)

Oxykal, Neo-paraderma

Intervention Description

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

Intervention Name(s)

1% permethrin

Other Intervention Name(s)

Nix cream rinse

Intervention Description

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.

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Any adverse events during or after application of the product

Time Frame

up to 7 or 8 d after product application

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lidia Serrano, CRI

Organizational Affiliation

Lice Source Services

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lice Source Services Inc

City

Plantation

State/Province

Florida

ZIP/Postal Code

33313

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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