Two Treatment Regimens of Cocamide DEA Lotion for Head Lice

Pediculosis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02499549
• Other study ID #: CTRL02
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: July 10, 2015
• Last updated: July 15, 2015
• Start date: October 1999
• Est. completion date: December 1999

Study information

• Verified date: July 2015
• Source: Medical Entomology Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 112
• Est. completion date: December 1999
• Est. primary completion date: December 1999
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head Louse Infestation
• Lice Infestations
• Pediculosis

Intervention

Drug:
• cocamide diethanolamine
10% Cocamide DEA aqueous lotion is applied directly to dry hair and is washed off with water only

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical Entomology Centre	Riemann a/s

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful elimination of infestation	No evidence of active head lice infestation 14 days after enrolment	14 days	No
Secondary	Number of participants with treatment related adverse events as a measure of safety	No treatment related adverse events following treatment	14 days	Yes