Study Stopped
Lack of efficacy
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.
1 other identifier
interventional
112
0 countries
N/A
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 1999
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 1999
CompletedFirst Submitted
Initial submission to the registry
July 10, 2015
CompletedFirst Posted
Study publicly available on registry
July 16, 2015
CompletedJuly 16, 2015
July 1, 2015
2 months
July 10, 2015
July 15, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Successful elimination of infestation
No evidence of active head lice infestation 14 days after enrolment
14 days
Secondary Outcomes (1)
Number of participants with treatment related adverse events as a measure of safety
14 days
Study Arms (2)
10% Cocamide diethanolamine 8 hours
EXPERIMENTALCocamide DEA topical lotion applied 8 hours/overnight with drying
10% Cocamide diethanolamine 2 hours
EXPERIMENTALCocamide DEA topical lotion applied 2 hours with drying, repeated after 7 days
Interventions
10% Cocamide DEA aqueous lotion is applied directly to dry hair and is washed off with water only
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical Entomology Centrelead
- Riemann a/scollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ian F Burgess
Medical Entomology Centre
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2015
First Posted
July 16, 2015
Study Start
October 1, 1999
Primary Completion
December 1, 1999
Study Completion
December 1, 1999
Last Updated
July 16, 2015
Record last verified: 2015-07