Two Treatment Regimens of Cocamide DEA Lotion for Head Lice

A Randomised, Parallel Group Clinical Trial to Assess the Efficacy, Safety and Acceptability of a Surfactant Based Lotion in the Treatment of Head Louse Infection.

To assess the efficacy and safety of 10% Cocamide DEA using two treatment regimens in the eradication of head lice. To assess the ability of each treatment regimen to kill all viable ova and to assess patient acceptability of the product in use

Study Overview

• Status: Terminated
• Conditions: Pediculosis; Head Louse Infestation
• Intervention / Treatment: Drug: cocamide diethanolamine

Detailed Description

A previous study found that a formulation of 10% cocamide diethanolamine (DEA) aqueous lotion showed some efficacy to eliminate head louse infestation but that the treatment regimen was inadequate to kill all lice or louse eggs. This study has been designed to compare two different application regimens that have been shown effective in vitro.

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 10% cocamide DEA lotion using the appropriate treatment regimen according to the randomization code from a pre-prepared listing in balanced blocks of 12.

Group 1: 10% cocamide DEA is applied directly to dry hair, the excess water evaporated off using a hair dryer and is then left for 8 hour/overnight before washing off with clean water.

Group 2: 10% cocamide DEA is applied directly to dry hair, the excess water evaporated off using a hair dryer and is then left for 2 hours before washing off with clean water. A follow up treatment is given after 7 days.

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, 8,11 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.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female patients over the age of 4 who are found to have a head louse infection.
• Patients who give written informed consent and, 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 paraben preservatives.
• Patients who have been treated with other head lice products within the last 2 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 whose hair has been bleached, colour treated or permed within the last 4 weeks.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10% Cocamide diethanolamine 8 hours; Cocamide DEA topical lotion applied 8 hours/overnight with drying	Drug: cocamide diethanolamine; 10% Cocamide DEA aqueous lotion is applied directly to dry hair and is washed off with water only; Other Names: lauramine diethanolamine
Experimental: 10% Cocamide diethanolamine 2 hours; Cocamide DEA topical lotion applied 2 hours with drying, repeated after 7 days	Drug: cocamide diethanolamine; 10% Cocamide DEA aqueous lotion is applied directly to dry hair and is washed off with water only; Other Names: lauramine diethanolamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful elimination of infestation	No evidence of active head lice infestation 14 days after enrolment	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment related adverse events as a measure of safety	No treatment related adverse events following treatment	14 days

Collaborators and Investigators

• Sponsor: Medical Entomology Centre
• Collaborators: Riemann a/s
• Investigators: Principal Investigator: Ian F Burgess, Medical Entomology Centre

Study record dates

Study Major Dates

• Study Start: October 1, 1999
• Primary Completion (Actual): December 1, 1999
• Study Completion (Actual): December 1, 1999

Study Registration Dates

• First Submitted: July 10, 2015
• First Submitted That Met QC Criteria: July 15, 2015
• First Posted (Estimate): July 16, 2015

Study Record Updates

• Last Update Posted (Estimate): July 16, 2015
• Last Update Submitted That Met QC Criteria: July 15, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Parasitic Diseases; Ectoparasitic Infestations; Skin Diseases, Parasitic; Skin Diseases, Infectious; Lice Infestations
• Other Study ID Numbers: CTRL02