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Completed

NCT Number: NCT00672971

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

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.

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Key information

Conditions

Head Lice

Age range

4 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lice Source Services Inc

Plantation, Florida, 33313, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4% dimethicone foam

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.

Other names: Oxykal, Neo-paraderma

1% permethrin

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.

Other names: Nix cream rinse

Primary outcomes

  1. 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 outcomes

  1. Any adverse events during or after application of the product

    Time frame: up to 7 or 8 d after product application

Sponsors and collaborators

Lead sponsor

Oystershell NV

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
May 6, 2008
Registry last updated
May 6, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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