Cocamide DEA vs Permethrin for Head Lice

Pediculosis Capitis Clinical Trial

Official title:

A Randomised, Controlled, Assessor-blind, Parallel Group Clinical Trial to Assess the Efficacy, Safety and Acceptability of a Surfactant Based Lotion and a Permethrin Creme Rinse in the Treatment of Head Lice

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02500524
• Other study ID #: CTRL01
• Status: Terminated
• Phase: Phase 3
• First received: July 10, 2015
• Last updated: July 14, 2015
• Start date: July 1998
• Est. completion date: January 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 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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: January 1999
• Est. primary completion date: January 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 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.

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 Capitis

Intervention

Drug:
• Cocamide diethanolamine
Topical lotion
• Permethrin
Topical creme rinse

Locations

Country	Name	City	State
United Kingdom	Medical Entomology Centre	Cambridge

Sponsors (3)

Lead Sponsor	Collaborator
Medical Entomology Centre	PN Lee Statistics and Computing Ltd, Riemann a/s

Country where clinical trial is conducted

United Kingdom, 

Outcome

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