PediculosisPhase 2/3NCT02499549
Two Treatment Regimens of Cocamide DEA Lotion for Head Lice
A Phase 2/3 study testing cocamide diethanolamine in people with Pediculosis and Head Louse Infestation, run by Medical Entomology Centre.
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 Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pediculosis, Head Louse Infestation
- What is being tested?
- cocamide diethanolamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- Oct 1999to Dec 1999
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
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
Read the 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.
- Conditions
- Pediculosis, Head Louse Infestation
- Being tested
- cocamide diethanolamine
- Medical subject headings
- Lice Infestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cocamide diethanolamineDrug
Also called lauramine diethanolamine
10% Cocamide DEA aqueous lotion is applied directly to dry hair and is washed off with water only
| Study group | Role | What they receive |
|---|---|---|
| 10% Cocamide diethanolamine 8 hours | Experimental | Cocamide DEA topical lotion applied 8 hours/overnight with drying Receives: Drug: cocamide diethanolamine |
| 10% Cocamide diethanolamine 2 hours | Experimental | Cocamide DEA topical lotion applied 2 hours with drying, repeated after 7 days Receives: Drug: cocamide diethanolamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful elimination of infestation
No evidence of active head lice infestation 14 days after enrolment
Measured: 14 days
Secondary outcomes (1)
Number of participants with treatment related adverse events as a measure of safety
No treatment related adverse events following treatment
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startOct 1999
- Primary completionDec 1999
- Study completionDec 1999
Why it stopped: Lack of efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Entomology Centre
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Riemann a/s
- Responsible party
- Sponsor
- Investigators
- Ian F Burgess, Principal investigator, Medical Entomology Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02499549
- Sponsor's protocol ID
- CTRL02
- Status last verified
- Jul 2015
- First submitted
- 10 Jul 2015
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02499549
- Acronym / sponsor ID
- CTRL02
- Conditions
- Pediculosis, Head Louse Infestation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Medical Entomology CentreIndustry (pharma, biotech, devices)
- Collaborators
- Riemann a/s
- Study start
- Oct 1999
- Primary completion
- Dec 1999 (actual)
- Study completion
- Dec 1999 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10% Cocamide diethanolamine 8 hours | Experimental | Drug: cocamide diethanolamineCocamide DEA topical lotion applied 8 hours/overnight with drying |
| 10% Cocamide diethanolamine 2 hours | Experimental | Drug: cocamide diethanolamineCocamide DEA topical lotion applied 2 hours with drying, repeated after 7 days |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cocamide diethanolamineAlso: lauramine diethanolamine10% Cocamide DEA aqueous lotion is applied directly to dry hair and is washed off with water only | Drug | 10% Cocamide diethanolamine 2 hours, 10% Cocamide diethanolamine 8 hours |
Primary outcome
Successful elimination of infestation
Time frame: 14 days
No evidence of active head lice infestation 14 days after enrolment
1 secondary outcome
Number of participants with treatment related adverse events as a measure of safety
Time frame: 14 days
Results and safety
The study was stopped early (reason given: Lack of efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian F Burgess principal investigator
Medical Entomology Centre
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing cocamide diethanolamine in people with Pediculosis and Head Louse Infestation, run by Medical Entomology Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of efficacy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful elimination of infestation (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2015.