Cocamide DEA vs Permethrin for Head Lice

NCT02500524 | Terminated Phase 3

• 1 other identifier: CTRL01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediculosis Capitis; Head Louse Infestation

Outcome Measures

Primary Outcomes (1)

• Elimination of infestation

  No evidence of active head lice infestation 14 days after enrolment.

  14 days

Secondary Outcomes (1)

• The number of participants with treatment related adverse events as a measure of safety

  14 days

Study Arms (2)

10% Cocamide diethanolamine

EXPERIMENTAL

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

Drug: Cocamide diethanolamine

1% permethrin creme rinse

ACTIVE COMPARATOR

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.

Drug: Permethrin

Interventions

Cocamide diethanolamine DRUG

Topical lotion

Also known as: Lauramine diethanolamine

10% Cocamide diethanolamine

Permethrin DRUG

Topical creme rinse

1% permethrin creme rinse

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical Entomology Centre: lead
• PN Lee Statistics and Computing Ltd: collaborator
• Riemann a/s: collaborator

Study Sites (1)

Medical Entomology Centre

Cambridge, CB25 9AU, United Kingdom

Location

MeSH Terms

Interventions

coconut diethanolamide; Permethrin

Intervention Hierarchy (Ancestors)

Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pyrethrins; Cyclopentane Monoterpenes; Monoterpenes; Terpenes

Study Officials

• Ian F Burgess

  Medical Entomology Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 10, 2015
• First Posted: July 16, 2015
• Study Start: July 1, 1998
• Primary Completion: January 1, 1999
• Study Completion: January 1, 1999
• Last Updated: July 16, 2015

Record last verified: 2015-07

Locations

GB (1)