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Two Treatment Regimens of Cocamide DEA Lotion for Head Lice

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ClinicalTrials.gov Identifier: NCT02499549
Recruitment Status : Terminated (Lack of efficacy)
First Posted : July 16, 2015
Last Update Posted : July 16, 2015
Sponsor:
Collaborator:
Riemann a/s
Information provided by (Responsible Party):
Medical Entomology Centre

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

Condition or disease Intervention/treatment Phase
Pediculosis Head Louse Infestation Drug: cocamide diethanolamine Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : October 1999
Actual Primary Completion Date : December 1999
Actual Study Completion Date : December 1999

Resource links provided by the National Library of Medicine


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 Name: 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 Name: lauramine diethanolamine




Primary Outcome Measures :
  1. Successful elimination of infestation [ Time Frame: 14 days ]
    No evidence of active head lice infestation 14 days after enrolment


Secondary Outcome Measures :
  1. Number of participants with treatment related adverse events as a measure of safety [ Time Frame: 14 days ]
    No treatment related adverse events following treatment



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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02499549


Sponsors and Collaborators
Medical Entomology Centre
Riemann a/s
Investigators
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Principal Investigator: Ian F Burgess Medical Entomology Centre

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Responsible Party: Medical Entomology Centre
ClinicalTrials.gov Identifier: NCT02499549     History of Changes
Other Study ID Numbers: CTRL02
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: July 16, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
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Lice Infestations
Parasitic Diseases
Ectoparasitic Infestations
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases