Cocamide DEA vs Permethrin for Head Lice

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-07-31

Study Completion Date

1999-01-31

Brief Summary

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To assess the efficacy and safety of 10% Cocamide DEA and Lyclear creme rinse (permethrin1%) in the eradication of head lice. To assess the ability of each product to kill all viable ova and to assess patient acceptability of the product in use.

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Detailed Description

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A formulation of cocamide diethanolamine (DEA) surfactant was previously reported as showing efficacy to eliminate head louse infestation. This study has been designed to test those data using a new formulation of 10% cocamide DEA in an aqueous basis in comparison with the standard of care product 1% permethrin creme rinse. It is believed that surfactants like cocamide DEA are capable of eliminating lice resistant to conventional insecticides.

A planned total of 120 patients who, following examination, are found to suffer from active head lice infestation will be recruited to the trial. The patient will be treated with the appropriate product according to the randomization code from a pre-prepared listing in balanced blocks of 12.

10% Cocamide DEA is applied directly to dry hair and is washed off with shampoo after 60 minutes. Permethrin 1% creme rinse is applied to shampooed and towel dried hair and left in situ for 10 minutes, then rinsed off with clean water. Treatments will be applied by experienced investigators throughout the study. Assessments will be made by other investigators unaware of the treatment regimen used.

After treatment (day 0), follow up assessments will be performed on days 4, 7,10 then again at day 14 after which they will leave the study. Any adverse events or side effects from the treatments will be monitored during the study.

Conditions

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Pediculosis Capitis Head Louse Infestation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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10% Cocamide diethanolamine

10% Cocamide DEA aqueous lotion is applied directly to dry hair on a single occasion and is washed off with shampoo after 60 minutes.

Group Type EXPERIMENTAL

Cocamide diethanolamine

Intervention Type DRUG

Topical lotion

1% permethrin creme rinse

1% permethrin creme rinse is applied to shampooed and towel dried hair on a single occasion and left in situ for 10 minutes, then rinsed off with clean water.

Group Type ACTIVE_COMPARATOR

Permethrin

Intervention Type DRUG

Topical creme rinse

Interventions

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Cocamide diethanolamine

Topical lotion

Intervention Type DRUG

Permethrin

Topical creme rinse

Intervention Type DRUG

Other Intervention Names

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Lauramine diethanolamine

Eligibility Criteria

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Inclusion Criteria

* Male and female patients over the age of 4 who are found to have a head lice infection.
* Patients who give written informed consent or, if the patient is under 16 years of age, whose guardian gives written informed consent to participate in the study.
* Available for the duration of study i.e. 15 days.

Exclusion Criteria

* Patients with a known sensitivity to pyrethroid, organophosphate, and/or carbamate insecticides, sensitivity to chrysanthemums and/or known sensitivity to paraben preservatives.
* Patients who have been treated with other head lice products within the last 4 weeks.
* Patients who have undergone a course of antibiotic treatment within the last 4 weeks.
* Patients who have any persistent skin disorder of the scalp (i.e. eczema, chronic dermatitis, psoriasis).
* Patients with asthma
* Patients whose hair has been bleached, colour treated or permed within the last 4 weeks.
* Pregnant or nursing mothers.
* Patients who have participated in another clinical trial within 1 month prior to entry to this study.
* Patients who have already participated in this clinical trial.

Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes