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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

Information source: Oystershell NV
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Head Lice

Intervention: 4% dimethicone foam (Other); 1% permethrin (Other)

Phase: N/A

Status: Completed

Sponsored by: Oystershell NV

Official(s) and/or principal investigator(s):
Lidia Serrano, CRI, Principal Investigator, Affiliation: Lice Source Services

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.

Clinical Details

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

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

Primary outcome: 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: Any adverse events during or after application of the product

Eligibility

Minimum age: 4 Years. Maximum age: 85 Years. Gender(s): Both.

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

Locations and Contacts

Lice Source Services Inc, Plantation, Florida 33313, United States
Additional Information

Starting date: September 2007
Ending date: November 2007
Last updated: May 5, 2008

Page last updated: June 20, 2008

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