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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

O

Oystershell

Status

Completed

Conditions

Head Lice

Treatments

Other: 1% permethrin
Other: 4% dimethicone foam

Study type

Interventional

Funder types

Industry

Identifiers

NCT00672971
OYS001-07

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

4 to 85 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

31 participants in 2 patient groups

1
Experimental group
Description:
4% dimethicone foam
Treatment:
Other: 4% dimethicone foam
2
Active Comparator group
Description:
1% permethrin
Treatment:
Other: 1% permethrin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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