Expired Study
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Plantation, Florida 33313


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.


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


Study is Available At:


Original ID:

OYS001-07


NCT ID:

NCT00672971


Secondary ID:


Study Acronym:


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.


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

4 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Oystershell NV


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

31


Enrollment Type:

Actual


Overall Contact Information

Official Name:Lidia Serrano, CRI
Principal Investigator
Lice Source Services

Study Dates

Start Date:September 2007
Completion Date:November 2007
Completion Type:Actual
Primary Completion Date:November 2007
Primary Completion Type:Actual
Verification Date:May 2008
Last Changed Date:May 5, 2008
First Received Date:May 2, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Any adverse events during or after application of the product
Time Frame:up to 7 or 8 d after product application
Safety Issues:True

Study Interventions

Intervention Type:Other
Name:4% dimethicone foam
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.
Arm Name:1
Other Name:Oxykal, Neo-paraderma
Intervention Type:Other
Name:1% permethrin
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.
Arm Name:2
Other Name:Nix cream rinse

Study Arms

Study Arm Type:Active Comparator
Arm Name:2
Description:1% permethrin
Study Arm Type:Experimental
Arm Name:1
Description:4% dimethicone foam

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Oystershell NV

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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