Pediculus Humanus Capitis (Head Lice)Phase 2NCT00857948

Dose Ranging Study of Ivermectin Treatment Conditioner in Subjects With Head Lice Infestation

A Phase 2 study testing ivermectin treatment conditioner in people with Pediculus Humanus Capitis (Head Lice), run by Topaz Pharmaceuticals Inc at 1 site 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

This is a Phase 2 single center study designed to compare the safety, local tolerability, and efficacy of 3 strengths of ivermectin treatment conditioner to placebo. Read more about this study

Who is it for?: Ages 6 months and older
Conditions the study is for: Pediculus Humanus Capitis (Head Lice)
What is being tested?: ivermectin treatment conditioner
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 78 participants
Where: 1 siteUnited States
Study dates: Mar 2009to Apr 2009
Phase: Phase 2
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 and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Subjects who are at least 6 months old and weighing at least 15 kg.
Infestation with head lice and viable nits.
Are otherwise in a normal state of health.
Willing and able to attend all study visits as scheduled.
Agree not to cut or chemically treat their hair in the period between treatment and the final visit.
The subject and/or his/her parent/legal guardian have provided written informed consent, and, if appropriate, the child has provided assent.
Females of childbearing potential must have a negative urine pregnancy test at screening and agree to take reasonable precautions against becoming pregnant during the study period.

Who cannot join

Subjects who have received any over the counter or prescription treatment for head lice in the last 2 weeks.
Subjects unable to comply with the study obligations and all study visits.
Subjects with eczema or other chronic conditions of the scalp and skin.
Subjects in a household with more than 5 infested members.
Subjects with a history of allergy to ivermectin or any ingredients commonly included in hair products such as shampoos, hair conditioners, or styling aids.
Subjects with neurologic conditions including a seizure disorder or history of seizures.

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Subjects with an infestation of body lice or pubic lice (determined by questioning).
Subjects suffering from a condition likely to require medical attention, including administration of oral or systemic antibiotics, oral or systemic corticosteroids, or any other treatment, which in the opinion of the Investigator and visiting physician could influence the results of the study.
Subjects with other diagnoses which, in the opinion of the Investigator, would interfere with efficacy or safety assessments or would preclude study participation.
Subjects with very short (shaved) hair.
Subjects who have been treated with a systemic antibiotic within the previous 2 weeks before screening.
Subjects who have been previously enrolled in any clinical study within the past 30 days; subjects may not participate in another study while participating in this study.
Pregnant and/or nursing females.

Trial locations and contacts

1 site in 1 country.

United States1 site

Global Health Associates of Miami
Miami, Florida, 33143

Other trials in United States

About this study

Official title: A Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of 3 Strengths of Ivermectin Treatment Conditioner and Placebo in Subjects With Pediculus Humanus Capitis (Head Lice) Infestation

This is a Phase 2 single center study designed to compare the safety, local tolerability, and efficacy of 3 strengths of ivermectin treatment conditioner to placebo.

Conditions: Pediculus Humanus Capitis (Head Lice)
Being tested: ivermectin treatment conditioner, Placebo, vehicle control
Keywords: head lice, Pediculus humanus capitis, ivermectin

What participants receive

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

ivermectin treatment conditionerDrug
Application followed by thorough rinsing of the hair and scalp with water.
Placebo, vehicle controlDrug
Application followed by thorough rinsing of the hair and scalp with water.

Study groups in NCT00857948
Study group	Role	What they receive
0.15% ivermectin	Experimental	Participant on 0.15% ivermectin treatment conditioner Receives: Drug: ivermectin treatment conditioner
0.25% ivermectin	Experimental	Participants on 0.25% ivermectin treatment conditioner Receives: Drug: ivermectin treatment conditioner
0.50% ivermectin	Experimental	Participants on 0.50% ivermectin treatment conditioner Receives: Drug: ivermectin treatment conditioner
Placebo	Placebo comparator	participants on Placebo (Vehicle control) Receives: Drug: Placebo, vehicle control

What is being measured

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

Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Live lice eradication was assessed by visual checks of hair and scalp on Days 1, 2 and 8 and by visual checks and counting both live and dead lice from rinse water on Day 15. Eradication was defined as cessation of motility (antennae and leg movement) in all lice.
Measured: Day 1 through Day 15 post-application

Secondary outcomes (3)

Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Live lice eradication was assessed on Days 1, 2, and 8 by visual checks of hair and scalp. Eradication was defined as cessation of motility (antennae and leg movement) in all lice.
Measured: Day 1 through Day 8 post-application
Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
The severity of lice infestation was determined by visual checks of hair and scalp. Severity was rated as None: no live lice; Mild: 1 to 5 live lice; Moderate: 6 to 10 live lice; Severe: 11 to 20 live lice; or Very severe > 20 live lice.
Measured: Day 1 through Day 15 post-application
Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control).
Measured: Day 1 up to Day 28 post-application

Timeline

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

Mar 2009Apr 2009

First posted9 Mar 2009 (estimated)
Study startMar 2009
Primary completionApr 2009
Study completionApr 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pediculus Humanus Capitis (Head Lice)Studies 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00857948
Sponsor's protocol ID: TOP003
Status last verified: Mar 2012
First submitted: 6 Mar 2009
Last updated: 30 Mar 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Meinking TL, Mertz-Rivera K, Villar ME, Bell M. Assessment of the safety and efficacy of three concentrations of topical ivermectin lotion as a treatment for head lice infestation. Int J Dermatol. 2013 Jan;52(1):106-12. doi: 10.1111/j.1365-4632.2012.05629.x.
PubMed 23278618

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of 3 Strengths of Ivermectin Treatment Conditioner and Placebo in Subjects With Pediculus Humanus Capitis (Head Lice) Infestation
ClinicalTrials.gov ID: NCT00857948
Acronym / sponsor ID: TOP003
Conditions: Pediculus Humanus Capitis (Head Lice)
Keywords: head lice, Pediculus humanus capitis, ivermectin
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: Topaz Pharmaceuticals IncIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Apr 2009 (actual)
Study completion: Apr 2009 (actual)
First posted: 9 Mar 2009 (estimated)
Results: Posted 30 Mar 2012

Clinical summary

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

This is a Phase 2 single center study designed to compare the safety, local tolerability, and efficacy of 3 strengths of ivermectin treatment conditioner to placebo.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
0.15% ivermectin	Experimental	Drug: ivermectin treatment conditionerParticipant on 0.15% ivermectin treatment conditioner
0.25% ivermectin	Experimental	Drug: ivermectin treatment conditionerParticipants on 0.25% ivermectin treatment conditioner
0.50% ivermectin	Experimental	Drug: ivermectin treatment conditionerParticipants on 0.50% ivermectin treatment conditioner
Placebo	Placebo comparator	Drug: Placebo, vehicle controlparticipants on Placebo (Vehicle control)

Who may qualify

Ages: 6 months and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

Subjects who are at least 6 months old and weighing at least 15 kg.
Infestation with head lice and viable nits.
Are otherwise in a normal state of health.
Willing and able to attend all study visits as scheduled.
Agree not to cut or chemically treat their hair in the period between treatment and the final visit.

Key exclusion criteria (13 listed)

Subjects who have received any over the counter or prescription treatment for head lice in the last 2 weeks.
Subjects unable to comply with the study obligations and all study visits.
Subjects with eczema or other chronic conditions of the scalp and skin.
Subjects in a household with more than 5 infested members.
Subjects with a history of allergy to ivermectin or any ingredients commonly included in hair products such as shampoos, hair conditioners, or styling aids.

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
ivermectin treatment conditionerApplication followed by thorough rinsing of the hair and scalp with water.	Drug	0.15% ivermectin, 0.25% ivermectin, 0.50% ivermectin
Placebo, vehicle controlApplication followed by thorough rinsing of the hair and scalp with water.	Drug	Placebo

Primary outcome

Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Time frame: Day 1 through Day 15 post-application
Live lice eradication was assessed by visual checks of hair and scalp on Days 1, 2 and 8 and by visual checks and counting both live and dead lice from rinse water on Day 15. Eradication was defined as cessation of motility (antennae and leg movement) in all lice.

3 secondary outcomes

Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Time frame: Day 1 through Day 8 post-application
Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Time frame: Day 1 through Day 15 post-application
Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control).
Time frame: Day 1 up to Day 28 post-application

Results and safety

Results posted to the registry on 30 Mar 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
0.15% Ivermectin	18	15
0.25% Ivermectin	18	18
0.50% Ivermectin	19	18
Placebo	23	23

Primary outcome: Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)

Time frame: Day 1 through Day 15 post-application. Number. Unit: Percent of participants

Measure	0.15% Ivermectin n = 18	0.25% Ivermectin n = 18	0.50% Ivermectin n = 19	Placebo n = 23
Value	56	50 (0 to 0)	74 (0 to 0)	9 (0 to 0)

Population analysed: Live lice eradication was assessed in the Intent-to-treat Population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from Day 1 up to Day 28 post-application.. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0.15% Ivermectin	0 of 18 (0%)	6 of 18 (33.3%)	Not reported
0.25% Ivermectin	0 of 18 (0%)	3 of 18 (16.7%)	Not reported
0.50% Ivermectin	0 of 19 (0%)	5 of 19 (26.3%)	Not reported
Placebo	0 of 23 (0%)	5 of 23 (21.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23278618Meinking TL, Mertz-Rivera K, Villar ME, Bell M. Assessment of the safety and efficacy of three concentrations of topical ivermectin lotion as a treatment for head lice infestation. Int J Dermatol. 2013 Jan;52(1):106-12. doi: 10.1111/j.1365-4632.2012.05629.x.

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

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ivermectin treatment conditioner in people with Pediculus Humanus Capitis (Head Lice), run by Topaz Pharmaceuticals Inc at 1 site 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 7 inclusion and 13 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 30 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 30 Mar 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?

Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control) (time frame: Day 1 through Day 15 post-application). 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 NCT00857948, which also lists 1 linked publication.

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 30 Mar 2012.