Head LicePhase 2NCT00994422

Study Comparing the Safety and Efficacy of 0.5% Ivermectin Cream to Placebo in Lice Infested Subjects

A Phase 2 study testing Ivermectin cream in people with Head Lice, run by Topaz Pharmaceuticals Inc at 12 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 compare the safety and efficacy of a 0.5% ivermectin cream to a placebo in subjects infested with head lice when used in an "at home" environment. Read more about this study

Who is it for?: Ages 2 years and older
Conditions the study is for: Head Lice
What is being tested?: Ivermectin cream
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 264 participants
Where: 12 sitesUnited States
Study dates: Oct 2009to Dec 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 2 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Subject must have an active head lice infestation defined as: At least 1 live louse (adult and/or nymph) present on the scalp and/or hair, as determined by a trained evaluator (with the exception of the male head of household who may self-assess as being lice free).
Subject is male or female.
Subject weighs at least 15kg (33 lbs).
Subject is in good general health based on medical history.
Each subject must have an appropriately signed Informed Consent agreement. A caregiver must sign an Informed Consent agreement for children not old enough to do so. Children of a specified age will be administered a child's assent form.
The caregiver of a subject must be willing to allow all household members to be screened for head lice. If other household members are found to have an active head lice infestation, according to the criteria a (above), they must be willing and able to participate in the study. No more than one working male per family may be excluded from evaluation if he is self-assessed as being lice free and cannot come in due to his work schedule. If this individual may have lice, he must come to the test facility; otherwise the entire household will be excluded from study participation.

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Subject and/or their caregiver must be physically able and willing to apply the test article.
Subject agrees not to use any other form of lice treatments (commercial, community-anecdotal, or mechanical/manual) while they are participating in the study.
Following application and rinsing of Study Treatment, subject agrees not to shampoo, wash, or rinse their hair or scalp until the 24-hour post-treatment evaluation has been completed.
Subject agrees that they will not cut or chemically treat their hair while they are participating in the study.
Subject agrees to follow all study instructions.
Female subjects of childbearing potential (including a female caregiver even if she is not being treated) must be willing to have a urine pregnancy test.
In the event of a subject judged to be incapable of self-treating, the household must have a caregiver willing to apply the treatment at home.

Who cannot join

History of irritation or sensitivity to ivermectin or the cream components, pediculicides or hair care products.
Presentation at the treatment site with visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score that is >2, blisters, vesicles which, in the opinion of the investigative personnel or sponsor, will interfere with safety and/or efficacy evaluations.
Presentation at the treatment site with eczema or atopic dermatitis on the skin/scalp.
Treatment with a marketed pediculicide (Over the counter [OTC] or Prescription) in the last 7 days.
Any condition or illness that, in the opinion of the investigator, may compromise the objective of the protocol.
Is receiving any other treatment which, in the opinion of the investigator or study monitor, may interfere with the study results.

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Females (including caregivers who come in contact with the investigational product) who are pregnant, nursing or planning a pregnancy. (NOTE: female caregivers and all enrolled females of childbearing potential must have a negative urine pregnancy test prior to treatment). If a household has a pregnant female who has an active case of lice, the entire household is excluded from participation. If this pregnant household member does not have an active infestation, this individual must NOT be the caregiver (one who provides treatment to other household members).
Is of child-bearing potential and unwilling to use an adequate method of contraception for the duration of the study. Adequate methods of contraception include: abstinence, vasectomized partner, oral birth control pills, birth control injections or patches, Intra Uterine Devices, condoms with a spermicidal jelly or a diaphragm with spermicidal jelly, surgical sterilization.
Participation in a previous investigational drug study within the past 30 days.
Does not understand the requirements for study participation and/or may likely exhibit poor compliance, in the opinion of the investigator.
Does not have a known household affiliation with their household members (i.e., do not stay in one household consistently, sleeping at one place several nights and then at another place or location). Household is defined as living in a shared area or space (for example the same house or apartment unit).

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Lovelace Scientific Resources, Inc.
Albuquerque, New Mexico, 87108
Haywood Pediatric Adolescent Medicine Group, PA
Clyde, North Carolina, 28721
Lice Cleanique, LLC
Delray Beach, Florida, 33484
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Northeast Houston Pediatric Clinic
Houston, Texas, 77015
Impact Clinical Trials
Los Angeles, California, 90057
Hill Top Research Corp.
Miamiville, Ohio, 45147
LSRN
Nashville, Tennessee, 37206
Virgina Clinical Research, Inc.
Norfolk, Virginia, 23507
Hill-Top Research Corp
St. Petersburg, Florida, 33710
LSRN
West Palm Beach, Florida, 33407
Cactus Kids Pediatrics
Yuma, Arizona, 85364

Other trials in United States

About this study

Official title: A Double-Blind Randomized Study to Compare the Safety, Local Tolerability and Efficacy of a 0.5% Ivermectin Cream Compared to a Topical Vehicle Control in Subjects With Pediculus Humanus Capitis Infestation

The purpose of this study is to compare the safety and efficacy of a 0.5% ivermectin cream to a placebo in subjects infested with head lice when used in an "at home" environment.

Conditions: Head Lice
Being tested: Ivermectin cream, vehicle control
Keywords: PEDICULUS HUMANUS CAPITIS, Head Lice

What participants receive

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

Ivermectin creamDrug
Up to 4 ounces of topical 0.5% Ivermectin Cream applied to the hair and scalp on day 1.
vehicle controlDrug
Up to 4 ounces of vehicle control applied to the hair and scalp on day 1

Study groups in NCT00994422
Study group	Role	What they receive
0.5% ivermectin cream	Experimental	Not described Receives: Drug: Ivermectin cream
vehicle control	Placebo comparator	Not described Receives: Drug: vehicle control

What is being measured

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

Percentage of Participants With Treatment Success Following Treatment With Either Ivermectin or Placebo (Vehicle Control)
Treatment success was defined as the absence of live lice and was determined by visual examination of hair and scalp by a trained evaluator.
Measured: Days 2 up to Day 15 post-treatment
Number of Participants Reporting Adverse Events Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Measured: Day 1 up to Day 28 post-application
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Participants skin/scalp irritations were assessed before treatment (Day 1) and Post-treatment with either Ivermectin or placebo by a trained evaluator.
Severe scalp irritations were defined as follows:
Severe Pruritus - Nearly constant, frequent scratching, very bothersome; Severe Erythema - Large areas of the scalp are red; Severe Excoriation: Widespread breaking of the skin involving most of the scalp; Severe Pyoderma - Lesions with crusting or other evidence of infection, involving most of the scalp.
Measured: Day 1 up to 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.

Oct 2009Dec 2009

First posted14 Oct 2009 (estimated)
Study startOct 2009
Primary completionDec 2009
Study completionDec 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 264 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00994422
Sponsor's protocol ID: TOP010
Status last verified: Apr 2012
First submitted: 9 Oct 2009
Last updated: 6 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 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind Randomized Study to Compare the Safety, Local Tolerability and Efficacy of a 0.5% Ivermectin Cream Compared to a Topical Vehicle Control in Subjects With Pediculus Humanus Capitis Infestation
ClinicalTrials.gov ID: NCT00994422
Acronym / sponsor ID: TOP010
Conditions: Head Lice
Keywords: PEDICULUS HUMANUS CAPITIS, Head Lice
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 264 participants (actual)
Lead sponsor: Topaz Pharmaceuticals IncIndustry (pharma, biotech, devices)
Study start: Oct 2009
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 14 Oct 2009 (estimated)
Results: Posted 4 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 compare the safety and efficacy of a 0.5% ivermectin cream to a placebo in subjects infested with head lice when used in an "at home" environment.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
0.5% ivermectin cream	Experimental	Drug: Ivermectin cream
vehicle control	Placebo comparator	Drug: vehicle control

Who may qualify

Ages: 2 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (13 listed)

Subject must have an active head lice infestation defined as: At least 1 live louse (adult and/or nymph) present on the scalp and/or hair, as determined by a trained evaluator (with the exception of the male head of household who may self-assess as being lice free).
Subject is male or female.
Subject weighs at least 15kg (33 lbs).
Subject is in good general health based on medical history.
Each subject must have an appropriately signed Informed Consent agreement. A caregiver must sign an Informed Consent agreement for children not old enough to do so. Children of a specified age will be administered a child's assent form.

Key exclusion criteria (11 listed)

History of irritation or sensitivity to ivermectin or the cream components, pediculicides or hair care products.
Presentation at the treatment site with visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score that is >2, blisters, vesicles which, in the opinion of the investigative personnel or sponsor, will interfere with safety and/or efficacy evaluations.
Presentation at the treatment site with eczema or atopic dermatitis on the skin/scalp.
Treatment with a marketed pediculicide (Over the counter [OTC] or Prescription) in the last 7 days.
Any condition or illness that, in the opinion of the investigator, may compromise the objective of the protocol.

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 creamUp to 4 ounces of topical 0.5% Ivermectin Cream applied to the hair and scalp on day 1.	Drug	0.5% ivermectin cream
vehicle controlUp to 4 ounces of vehicle control applied to the hair and scalp on day 1	Drug	vehicle control

Primary outcome

Percentage of Participants With Treatment Success Following Treatment With Either Ivermectin or Placebo (Vehicle Control)
Time frame: Days 2 up to Day 15 post-treatment
Treatment success was defined as the absence of live lice and was determined by visual examination of hair and scalp by a trained evaluator.
Number of Participants Reporting Adverse Events Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Time frame: Day 1 up to Day 28 post-application
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Time frame: Day 1 up to Day 15 post-application
Participants skin/scalp irritations were assessed before treatment (Day 1) and Post-treatment with either Ivermectin or placebo by a trained evaluator. Severe scalp irritations were defined as follows: Severe Pruritus - Nearly constant, frequent scratching, very bothersome; Severe Erythema - Large areas of the scalp are red; Severe Excoriation: Widespread breaking of the skin involving most of the scalp; Severe Pyoderma - Lesions with crusting or other evidence of infection, involving most of the scalp.

Results and safety

Results posted to the registry on 4 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	192	185
Placebo (Vehicle Control)	55	54

Primary outcome: Percentage of Participants With Treatment Success Following Treatment With Either Ivermectin or Placebo (Vehicle Control)

Time frame: Days 2 up to Day 15 post-treatment. Number. Unit: Percent of Participants

Measure	0.5% Ivermectin n = 192	Placebo (Vehicle Control) n = 55
Day 2 (N = 192, 55)	95	53 (0 to 0)
Day 8 (N = 191, 55)	83	49 (0 to 0)
Day 15 (N = 185, 54)	76	35 (0 to 0)

Population analysed: Treatment success 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.

Primary outcome: Number of Participants Reporting Adverse Events Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)

Time frame: Day 1 up to Day 28 post-application. Number. Unit: Participants

Measure	0.5% Ivermectin n = 192	Vehicle Control n = 55
Conjunctivitis	1	0 (0 to 0)
Application site pruritus	1	1 (0 to 0)
Influenza	2	0 (0 to 0)
Nail bed infection	1	0 (0 to 0)
Pharyngitis	1	0 (0 to 0)
Pyoderma	1	0 (0 to 0)
Swine influenza	1	0 (0 to 0)
Upper respiratory tract infection	5	0 (0 to 0)

Population analysed: Adverse events were assessed in the Intent-to-treat (Safety) population.

Primary outcome: Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)

Time frame: Day 1 up to Day 15 post-application. Number. Unit: Participants

Measure	0.5% Ivermectin n = 192	Vehicle Control n = 55
Any Erythema Day 1 (Pre-treatment; N = 192, 55)	26	5 (0 to 0)
Severe Erythema Day 1 (Pre-treatment; N = 192, 55)	0	0 (0 to 0)
Any Erythema Day 2 (N = 192, 55)	18	3 (0 to 0)
Severe Erythema Day 2 (N = 192, 55)	0	0 (0 to 0)
Any Erythema Day 8 (N = 181, 29)	7	0 (0 to 0)
Severe Erythema Day 8 (N = 181, 29)	0	0 (0 to 0)
Any Erythema Day 15 (N = 152, 26)	3	0 (0 to 0)
Severe Erythema Day 15 (N = 152, 26)	0	0 (0 to 0)

Population analysed: Local tolerability was assessed in the Intent-to-treat (Safety) population.

Adverse events

Time frame: Adverse event data were collected form Day 1 up to Day 28 post-treatment with either Ivermectin or Placebo. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0.5% Ivermectin	0 of 192 (0%)	8 of 192 (4.2%)	Not reported
Placebo (Vehicle Control)	0 of 55 (0%)	4 of 55 (7.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Head Lice

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Comparative Study for the Evaluation of a New Medical Device Shampoo on the Treatment of Head Lice Infestation
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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.

Medical Director study director

Sanofi Topaz

12 sites 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 cream in people with Head Lice, run by Topaz Pharmaceuticals Inc at 12 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 13 inclusion and 11 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 6 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 12 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. 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 4 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?

Percentage of Participants With Treatment Success Following Treatment With Either Ivermectin or Placebo (Vehicle Control) (time frame: Days 2 up to Day 15 post-treatment). The study lists 3 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 NCT00994422.

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 6 Apr 2012.