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

NCT00672971 | Completed

• 1 other identifier: OYS001-07
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Head Lice

Outcome Measures

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).

  14 or 15 days after 1st treatment

Secondary Outcomes (1)

• Any adverse events during or after application of the product

  up to 7 or 8 d after product application

Study Arms (2)

1

EXPERIMENTAL

4% dimethicone foam

Other: 4% dimethicone foam

2

ACTIVE COMPARATOR

1% permethrin

Other: 1% permethrin

Interventions

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.

Also known as: Oxykal, Neo-paraderma

1

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.

Also known as: Nix cream rinse

2

Eligibility Criteria

• Age: 4 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Oystershell NV: lead

Study Sites (1)

Lice Source Services Inc

Plantation, Florida, 33313, United States

Location

MeSH Terms

Interventions

Permethrin

Intervention Hierarchy (Ancestors)

Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pyrethrins; Cyclopentane Monoterpenes; Monoterpenes; Terpenes

Study Officials

• Lidia Serrano, CRI

  Lice Source Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 2, 2008
• First Posted: May 6, 2008
• Study Start: September 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: May 6, 2008

Record last verified: 2008-05

Locations

US (1)