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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00672971

Enrollment

Registered

2008-05-06

Start date

2007-09-30

Completion date

2007-11-30

Last updated

2008-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head Lice

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.

Interventions

OTHER4% dimethicone foam

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.

OTHER1% permethrin

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Any adverse events during or after application of the product	up to 7 or 8 d after product application

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026