Head LicePhase 3LICE OUTNCT01066585
A Safety and Efficacy Study Comparing 0.5% Ivermectin Cream to a Vehicle Control in Subjects With Head Lice Infestation
A Phase 3 study testing Ivermectin Cream in people with Head Lice, run by Topaz Pharmaceuticals Inc at 8 sites in United States.
Trial summary
The purpose of this study is to determine if 0.5% Ivermectin Cream is a safe and effective treatment for head lice infestations. Read more about this study
- Who is it for?
- Ages 6 months 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
- 410 participants
- Where
- 8 sitesUnited States
- Study dates
- Mar 2010to Jul 2010
- Phase
- Phase 3
- 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
- Index subjects must have an active head lice infestation defined as: At least 3 live lice (adults and/or nymphs) present on the scalp and/or hair, as determined by a trained evaluator. The index subject must be the youngest family member presenting with at least 3 live lice. After the index subject has been identified, additional infested household members (see b below) will be enrolled.
- Household subjects 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 is at least 6 months of age at time of enrollment.
- 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.
Show all 14Show fewer
- 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 b (above), they must be willing and able to participate in the study. No more than one working male per household may be excluded from evaluation if he is assessed as being lice free by himself or the caregiver 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.
- 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 participating in the study.
- Following application and rinsing of the test article, subject agrees not to shampoo, wash, or rinse their hair or scalp until the 24-hour post-treatment evaluation has been completed.
- Subject agrees to not cut or chemically treat their hair while 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.
- Treatment for head lice (Over the counter [OTC], home remedy and/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.
Show all 12Show fewer
- 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.
- Prior participation in any ivermectin trials.
- 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
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Universal Biopharma Research, Inc
Dinuba, California, 93618
McKenzie Medical Center
McKenzie, Tennessee, 38201
Hill Top Research
Miamiville, Ohio, 45147
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
Spence Medical Research
Picayune, Mississippi, 39466
Lice Source Services, Inc.
Plantation, Florida, 33313
LSRN
West Palm, Florida, 33407
Cactus Kids Pediatrics
Yuma, Arizona, 85364
About this study
Official title: A Double-Blind Randomized Study to Compare the Efficacy, Safety and Local Tolerability 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 determine if 0.5% Ivermectin Cream is a safe and effective treatment for head lice infestations.
- Conditions
- Head Lice
- Being tested
- Ivermectin Cream, vehicle control
- Keywords
- Head lice, Pediculus humanus capitis
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 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 Index Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Treatment success defined as absence of live lice, was assessed in index participants, defined as the youngest person within each household who had at least 3 live lice present at Screening (Day 1). Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation.
Measured: Day 2 up to Day 15 post-application
Secondary outcomes (3)
Percentage of All Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Treatment success, defined as absence of live lice, was assessed in all subjects. Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation.
Measured: Day 2 up to Day 15 post-application
Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severity of the adverse events were defined and classified as follows:
'Mild' - Awareness of signs or symptoms, but easily tolerated; 'Moderate' - Discomfort to a degree that adverse event/adverse drug reaction causes interference with normal daily life activities and/or requires medication; 'Severe' - Incapacity with regard to work or usual daily life activities. Requires medical attention/intervention.
Measured: Day 1 up to Day 15 post-application.
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe skin/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.
- First posted10 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2010
- Study completionJul 2010
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Topaz Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study chair, Sanofi Topaz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066585
- Sponsor's protocol ID
- TOP011
- Acronym
- LICE OUT
- Status last verified
- Apr 2012
- First submitted
- 8 Feb 2010
- Last updated
- 6 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pariser DM, Meinking TL, Bell M, Ryan WG. Topical 0.5% ivermectin lotion for treatment of head lice. N Engl J Med. 2012 Nov 1;367(18):1687-93. doi: 10.1056/NEJMoa1200107.
PubMed 23113480
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 Efficacy, Safety and Local Tolerability of a 0.5% Ivermectin Cream Compared to a Topical Vehicle Control in Subjects With Pediculus Humanus Capitis Infestation
- ClinicalTrials.gov ID
- NCT01066585
- Acronym / sponsor ID
- LICE OUT / TOP011
- Conditions
- Head Lice
- Keywords
- Head lice, Pediculus humanus capitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Topaz Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 10 Feb 2010 (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 determine if 0.5% Ivermectin Cream is a safe and effective treatment for head lice infestations.
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
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Index subjects must have an active head lice infestation defined as: At least 3 live lice (adults and/or nymphs) present on the scalp and/or hair, as determined by a trained evaluator. The index subject must be the youngest family member presenting with at least 3 live lice. After the index subject has been identified, additional infested household members (see b below) will be enrolled.
- Household subjects 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 is at least 6 months of age at time of enrollment.
- Subject is in good general health based on medical history.
Key exclusion criteria (12 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.
- Treatment for head lice (Over the counter [OTC], home remedy and/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 Index 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 2 up to Day 15 post-application
Treatment success defined as absence of live lice, was assessed in index participants, defined as the youngest person within each household who had at least 3 live lice present at Screening (Day 1). Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation.
3 secondary outcomes
Percentage of All 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 2 up to 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 15 post-application.
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Time frame: Day 1 up to Day 15 post-application
Results and safety
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.
- Derived from this study: PubMed 23113480Pariser DM, Meinking TL, Bell M, Ryan WG. Topical 0.5% ivermectin lotion for treatment of head lice. N Engl J Med. 2012 Nov 1;367(18):1687-93. doi: 10.1056/NEJMoa1200107.
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 chair
Sanofi Topaz
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ivermectin Cream in people with Head Lice, run by Topaz Pharmaceuticals Inc at 8 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 14 inclusion and 12 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 8 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 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?
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 Index 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 2 up to 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 NCT01066585, 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 6 Apr 2012.