Head LicePhase 1NCT00988533

A Pharmacokinetics (PK) Study in Lice Infested Children 6 Months to 3 Years of Age

A Phase 1 study testing 0.5% Ivermectin Cream in people with Head Lice, run by Topaz Pharmaceuticals Inc at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine the bioavailability of 0.5% ivermectin cream in a pediatric population aged 6 months to 3 years. Read more about this study

Who is it for?: Ages 6 months to 3 years
Conditions the study is for: Head Lice
What is being tested?: 0.5% Ivermectin Cream
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 5 sitesUnited States
Study dates: Sep 2009to Nov 2009
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 6 months to 3 years
All sexes
No healthy volunteers
Child

Who may be able to join

Subject must be 6 months to 3 years of age, inclusive, when informed consent is signed.
Subject must be infested with head lice as demonstrated by the presence of at least 1 live louse prior to treatment.
Subject is in general good health.
Subject's parent/guardian (caregiver) must be willing and able to bring subject to all study visits as scheduled.
Subject's caregiver must have provided written informed consent (assent is not required due to the young age of the subjects).
Subject's caregiver must agree to comply with the following study restrictions:

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will not use any other form of lice treatment (eg, commercial, community/anecdotal, or mechanical/manual) on the subject for the duration of the study, unless directed to do so by study personnel.
will not shampoo, wash, or rinse the subject's hair or scalp until the Day 2 treatment evaluation has been completed.
will not cut or chemically treat subject's hair in the period between screening and follow-up on Day 15.
will use only study-provided shampoo on the subject for the duration of the study.
will follow all study instructions.

Who cannot join

Subjects who have received any OTC or prescription treatment for head lice in the last 2 weeks.
Subjects or subjects' caregivers who are unable to comply with the study obligations and all study visits.
Subjects whose caregivers do not understand the requirements for participation and/or may be likely to exhibit poor compliance, in the opinion of the Investigator.
Subjects with eczema, atopic dermatitis, or other chronic conditions of the scalp and skin.
Subjects with visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score that is > 2, blisters, or any other condition that, in the opinion of the investigative personnel or Sponsor, would interfere with the PK, safety and/or efficacy evaluations.
Subjects with a history of allergy to ivermectin or any ingredients commonly included in hair products such as shampoos, hair conditioners, or styling aids.

Show all 10Show fewer

Subjects with other diagnoses that, in the opinion of the Investigator, would interfere with the PK, safety, and/or efficacy assessments or would preclude study participation.
Subjects who have been treated with a systemic antibiotic within 2 weeks before screening.
Subject currently taking warfarin sodium (Coumadin®) or has taken within 2 weeks before screening.
Subjects who have been enrolled in any clinical study within the past 30 days; subjects may not participate in another study while participating in this study.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Children's Investigational Research Program
Bentonville, Arkansas, 72712
Universal BioPharma Research, Inc
Dinuba, California, 93618
Impact Clinical Trials
Los Angeles, California, 90036
Spence Medical Research L.L.C
Picayune, Mississippi, 39466
Lice Source Solutions Inc
Plantation, Florida, 33313

Other trials in United States

About this study

Official title: An Open-label Study to Assess the Bioavailability, Safety, Local Tolerance, and Efficacy of 0.5% Ivermectin Cream in Subjects 6 Months to 3 Years of Age With Pediculus Humanus Capitis (Head Lice) Infestation

The purpose of this study is to determine the bioavailability of 0.5% ivermectin cream in a pediatric population aged 6 months to 3 years.

Conditions: Head Lice
Being tested: 0.5% Ivermectin Cream
Keywords: Head Lice, Pediculus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

0.5% Ivermectin CreamDrug
Topical 0.5% ivermectin cream applied to scalp and hair on day 1

Study groups in NCT00988533
Study group	Role	What they receive
0.5% Ivermectin Cream	Experimental	Not described Receives: Drug: 0.5% Ivermectin Cream

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points
Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods with a sensitivity of 0.05 ng/mL before application and on Day 1 (0.5, 1, and 6 hours), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).
Measured: Before; 0.5, 1, 6, 24 hours and Up to 14 days post-application
Summary of Pharmacokinetic Parameters Following Ivermectin Application.
Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).
Measured: Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application
Summary of Pharmacokinetic Parameter (Mean Concentration) Following Ivermectin Application.
Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).
Measured: Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application
Summary of Pharmacokinetic Parameter (Time of Observed Maximum Plasma Concentration) Following Ivermectin Application.
Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).
Measured: Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application

Secondary outcomes (5)

Number of Participants Reporting Adverse Events Following Ivermectin Treatment
Adverse events were assessed at each visit and during the follow up phone call on Day 28.
Measured: Day 1 up Day 28 post-application
Percentage of Participants Who Were Lice-Free by Visit Post-treatment With Ivermectin.
Eradication of live lice was assessed by visual examination of the scalp and hair.
Measured: Day 2, Day 8 and Day 15 post-application
Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 8 and Day 15 Post-treatment With Ivermectin.
Eradication of live lice was assessed by visual examination of the scalp and hair before and following application of Ivermectin.
Measured: Day 2, Day 8 and Day 15 post-application
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Liver function tests (Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase) were performed before Ivermectin application on Day 1 (baseline) and on Days 2, 8, and 15 after application.
Measured: Day 1, Day 2, Day 8 and Day 15 post-application
Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Liver function test (total bilirubin) was performed before treatment Day 1 (baseline) and following Ivermectin application on Days 2, 8, and 15 Post-application, respectively.
Measured: Day 1, Day 2, Day 8 and Day 15 post-application

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009Nov 2009

First posted2 Oct 2009 (estimated)
Study startSep 2009
Primary completionNov 2009
Study completionNov 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Head LiceStudies 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00988533
Sponsor's protocol ID: TOP008
Status last verified: Mar 2012
First submitted: 1 Oct 2009
Last updated: 25 Apr 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Safety, Efficacy and Preventative Effect of a Head Lice Product (X92001483) vs. Nix Creme Rinse (1% Permethrin).
Lice; Head Lice
Not yet recruiting
Comparative Study for the Evaluation of a New Medical Device Shampoo on the Treatment of Head Lice Infestation
Headlice
Not yet recruiting
Efficacy and Safetyof a Medical Device With a Physical Mode of Action (X92001919) Versus Paranix Anti-lice Shampoo.
Lice; Head Lice
Recruiting
Safety and Efficacy of Head-lice Treatments Elimax Green Lotion and Walgreens Lice Killing Shampoo
Head Lice

All Head Lice trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Study to Assess the Bioavailability, Safety, Local Tolerance, and Efficacy of 0.5% Ivermectin Cream in Subjects 6 Months to 3 Years of Age With Pediculus Humanus Capitis (Head Lice) Infestation
ClinicalTrials.gov ID: NCT00988533
Acronym / sponsor ID: TOP008
Conditions: Head Lice
Keywords: Head Lice, Pediculus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Topaz Pharmaceuticals IncIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: Nov 2009 (actual)
Study completion: Nov 2009 (actual)
First posted: 2 Oct 2009 (estimated)
Results: Posted 25 Apr 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine the bioavailability of 0.5% ivermectin cream in a pediatric population aged 6 months to 3 years.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
0.5% Ivermectin Cream	Experimental	Drug: 0.5% Ivermectin Cream

Who may qualify

Ages: 6 months to 3 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (11 listed)

Subject must be 6 months to 3 years of age, inclusive, when informed consent is signed.
Subject must be infested with head lice as demonstrated by the presence of at least 1 live louse prior to treatment.
Subject is in general good health.
Subject's parent/guardian (caregiver) must be willing and able to bring subject to all study visits as scheduled.
Subject's caregiver must have provided written informed consent (assent is not required due to the young age of the subjects).

Key exclusion criteria (10 listed)

Subjects who have received any OTC or prescription treatment for head lice in the last 2 weeks.
Subjects or subjects' caregivers who are unable to comply with the study obligations and all study visits.
Subjects whose caregivers do not understand the requirements for participation and/or may be likely to exhibit poor compliance, in the opinion of the Investigator.
Subjects with eczema, atopic dermatitis, or other chronic conditions of the scalp and skin.
Subjects with visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score that is > 2, blisters, or any other condition that, in the opinion of the investigative personnel or Sponsor, would interfere with the PK, safety and/or efficacy evaluations.

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
0.5% Ivermectin CreamTopical 0.5% ivermectin cream applied to scalp and hair on day 1	Drug	0.5% Ivermectin Cream

Primary outcome

Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points
Time frame: Before; 0.5, 1, 6, 24 hours and Up to 14 days post-application
Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods with a sensitivity of 0.05 ng/mL before application and on Day 1 (0.5, 1, and 6 hours), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).
Summary of Pharmacokinetic Parameters Following Ivermectin Application.
Time frame: Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application
Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).
Summary of Pharmacokinetic Parameter (Mean Concentration) Following Ivermectin Application.
Time frame: Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application
Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).
Summary of Pharmacokinetic Parameter (Time of Observed Maximum Plasma Concentration) Following Ivermectin Application.
Time frame: Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application
Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).

5 secondary outcomes

Number of Participants Reporting Adverse Events Following Ivermectin Treatment
Time frame: Day 1 up Day 28 post-application
Percentage of Participants Who Were Lice-Free by Visit Post-treatment With Ivermectin.
Time frame: Day 2, Day 8 and Day 15 post-application
Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 8 and Day 15 Post-treatment With Ivermectin.
Time frame: Day 2, Day 8 and Day 15 post-application
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Time frame: Day 1, Day 2, Day 8 and Day 15 post-application
Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Time frame: Day 1, Day 2, Day 8 and Day 15 post-application

Results and safety

Results posted to the registry on 25 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
0.5% Ivermectin	30	27

Primary outcome: Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points

Time frame: Before; 0.5, 1, 6, 24 hours and Up to 14 days post-application. Mean (Standard Deviation). Unit: ng/mL

Measure	0.5% Ivermectin n = 20
0 Hour (N = 20)	0.00000 (0.00000)
0.5 Hour (N = 19)	0.02528 (0.11018)
1 Hour (N = 19)	0.08192 (0.22695)
6 Hours (N = 19)	0.20075 (0.20456)
24 Hours (N = 18)	0.16325 (0.08983)
168 Hours (N = 2)	0.05767 (NA)

Population analysed: Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.

Primary outcome: Summary of Pharmacokinetic Parameters Following Ivermectin Application.

Time frame: Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application. Mean (Standard Deviation). Unit: ng/h/mL

Measure	0.5% Ivermectin n = 20
Time Averaged Plasma Concentration	0.08708 (0.11102)
Area Under Plasma Concentration Last	6.701 (11.23)
Area Under Plasma Concentration 0 to 24	3.972 (3.5142)

Population analysed: Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.

Primary outcome: Summary of Pharmacokinetic Parameter (Mean Concentration) Following Ivermectin Application.

Time frame: Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application. Mean (Standard Deviation). Unit: ng/mL

Measure	0.5% Ivermectin n = 20
Value	0.241 (0.23372)

Population analysed: Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.

Primary outcome: Summary of Pharmacokinetic Parameter (Time of Observed Maximum Plasma Concentration) Following Ivermectin Application.

Time frame: Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application. Mean (Standard Deviation). Unit: hour

Measure	0.5% Ivermectin n = 20
Value	15.9 (10)

Population analysed: Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from the day of application (Day 1) through Day 28 post-application. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0.5% Ivermectin	1 of 30 (3.3%)	11 of 30 (36.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Head Lice

Recruiting
Safety, Efficacy and Preventative Effect of a Head Lice Product (X92001483) vs. Nix Creme Rinse (1% Permethrin).
Lice; Head Lice
Not yet recruiting
Comparative Study for the Evaluation of a New Medical Device Shampoo on the Treatment of Head Lice Infestation
Headlice
Not yet recruiting
Efficacy and Safetyof a Medical Device With a Physical Mode of Action (X92001919) Versus Paranix Anti-lice Shampoo.
Lice; Head Lice
Recruiting
Safety and Efficacy of Head-lice Treatments Elimax Green Lotion and Walgreens Lice Killing Shampoo
Head Lice

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.

Medical Director study director

Sanofi Topaz

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 0.5% Ivermectin Cream in people with Head Lice, run by Topaz Pharmaceuticals Inc at 5 sites in United States.

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 11 inclusion and 10 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: finished, as of the sponsor's last update on 25 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points (time frame: Before; 0.5, 1, 6, 24 hours and Up to 14 days post-application). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00988533.

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 25 Apr 2012.