Head LicePhase 3NCT03337490
A Clinical Endpoint Bioequivalence Study to Assess Efficacy and Safety of Ivermectin 0.5% Lotion in the Treatment of Head Lice
A Phase 3 study testing Ivermectin 0.5% Topical Application Lotion and Ivermectin 0.5% Topical Application Lotion [SKLICE] in people with Head Lice, run by Mayne Pharma International Pty Ltd at 6 sites in United States.
Trial summary
This is a phase 3 randomized, multi-center, double-blind, placebo controlled, parallel group design study. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Head Lice
- What is being tested?
- Ivermectin 0.5% Topical Application Lotion and Ivermectin 0.5% Topical Application Lotion [SKLICE]
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 296 participants
- Where
- 6 sitesUnited States
- Study dates
- 2 Oct 2017to 18 Dec 2017
- 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 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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, through the age of 18, presenting with an active head lice infestation.
- Household members that 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) will receive the Standard of Care with an over-the-counter head lice treatment product. Up to 3 infested household members may receive treatment, if more than 3 household members are infested, the entire household will be excluded from the study.
- Subject is male or female.
- Index subject is at least 6 months through 18 years 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 ages 6-17 years of age will be administered a child's Assent Form.
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- 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, they must be willing and able to participate in receiving the Standard of Care. 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 product according to established treatment methods.
- 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 product, 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, including attending all follow-up appointments.
- Female index subjects of childbearing potential must be willing to have a urine pregnancy test prior to inclusion in this study.
- 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
- Index subjects with greater than 3 household members with at least 1 live louse (adult and/or nymph) present on the scalp and/or hair, as determined by a trained evaluator will be automatically excluded from the trial.
- Youngest household member is over 18 years of age.
- History of irritation or sensitivity to ivermectin or the lotion 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 medical monitor, 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 15 days.
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- 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 medical monitor, may interfere with the study results.
- Females (including caregivers who come in contact with the investigational product) who are pregnant, nursing or planning a pregnancy which could include index subjects. 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).
- Index subject 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. Index subjects and/or their caregivers will be considered non-child-bearing if the following has occurred: full hysterectomy or bilateral oophorectomy is considered surgically sterile. Tubal ligation is not considered equivalent to female 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
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Site 105
Dinuba, California, 93618
Site 104
Miami, Florida, 33186
Site 106
Nashville, Tennessee, 37217
Site 101
Plantation, Florida, 33313
Site 103
Richland, Washington, 99352
Site 102
West Palm Beach, Florida, 33407
About this study
Official title: A Randomized, Multi-Center, Double-blind, Placebo Controlled, Parallel Group Trial to Evaluate Efficacy and Safety of Mayne Pharma's Ivermectin 0.5% Lotion Compared to Sklice® Ivermectin 0.5% Lotion in the Treatment of Head Lice
This is a phase 3 randomized, multi-center, double-blind, placebo controlled, parallel group design study.
Read the detailed description
This study is comprised of two phases: screening and treatment. The screening period is 24 hours, followed by the treatment phase of 15 ± 3 days. During the treatment phase, subjects will be randomized to either test, reference of placebo treatments (3:3:1) in a double-blind manner in an outpatient setting. Once eligibility is confirmed, randomization will occur at visit 2 (baseline, Day 1) i.e. initiation of treatment phase. The treatment phase will be 15 ± 3 days in duration wherein subject will receive treatment with investigational product (either test, reference or placebo) on Day 1 or baseline (visit 2). Efficacy will be evaluated at Day 15. Safety and tolerability will be evaluated based upon AEs and patient self-assessments and self-assessments collected during follow-up visits.
- Conditions
- Head Lice
- Being tested
- Ivermectin 0.5% Topical Application Lotion, Ivermectin 0.5% Topical Application Lotion [SKLICE], Placebo 0% Lotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivermectin 0.5% Topical Application LotionDrug
Subjects on Test Product will receive a single dose, 117g, during the study to be applied at baseline.
Ivermectin 0.5% Topical Application Lotion [SKLICE]Drug
Subjects on Reference Product will receive a single dose, 117g, during the study to be applied at baseline.
Placebo 0% LotionDrug
Subjects on Placebo will receive a single dose, 117g, during the study to be applied at baseline.
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin 0.5% Lotion | Experimental | Ivermectin 0.5% lotion, topical, 117g, single dose Receives: Drug: Ivermectin 0.5% Topical Application Lotion |
| Ivermectin 0.5% Lotion [SKLICE] | Active comparator | Sklice 0.5% Lotion, topical, 117g, single dose Receives: Drug: Ivermectin 0.5% Topical Application Lotion [SKLICE] |
| Placebo 0% Lotion | Placebo comparator | 0% lotion, 117g, single dose Receives: Drug: Placebo 0% Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Index Subjects Who Are Lice Free at Day 15
The primary endpoint is the proportion of index subjects who are lice free at Day 15
Measured: 15 Days
Secondary outcomes (1)
The Number of All Index Subjects Who Are Lice-free at Day 2
The secondary endpoint includes the number of all index subjects who are lice-free at Day 2
Measured: 2 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start2 Oct 2017
- Primary completion4 Dec 2017
- Study completion18 Dec 2017
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayne Pharma International Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- bioRASI, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337490
- Sponsor's protocol ID
- MAP-7189
- Status last verified
- Aug 2020
- First submitted
- 30 Oct 2017
- Last updated
- 17 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-Center, Double-blind, Placebo Controlled, Parallel Group Trial to Evaluate Efficacy and Safety of Mayne Pharma's Ivermectin 0.5% Lotion Compared to Sklice® Ivermectin 0.5% Lotion in the Treatment of Head Lice
- ClinicalTrials.gov ID
- NCT03337490
- Acronym / sponsor ID
- MAP-7189
- Conditions
- Head Lice
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Mayne Pharma International Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- bioRASI, LLC
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 4 Dec 2017 (actual)
- Study completion
- 18 Dec 2017 (actual)
- First posted
- 9 Nov 2017 (actual)
- Results
- Posted 17 Sep 2020
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 3 randomized, multi-center, double-blind, placebo controlled, parallel group design study.
Detailed description
This study is comprised of two phases: screening and treatment. The screening period is 24 hours, followed by the treatment phase of 15 ± 3 days. During the treatment phase, subjects will be randomized to either test, reference of placebo treatments (3:3:1) in a double-blind manner in an outpatient setting. Once eligibility is confirmed, randomization will occur at visit 2 (baseline, Day 1) i.e. initiation of treatment phase. The treatment phase will be 15 ± 3 days in duration wherein subject will receive treatment with investigational product (either test, reference or placebo) on Day 1 or baseline (visit 2). Efficacy will be evaluated at Day 15. Safety and tolerability will be evaluated based upon AEs and patient self-assessments and self-assessments collected during follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ivermectin 0.5% Lotion | Experimental | Drug: Ivermectin 0.5% Topical Application LotionIvermectin 0.5% lotion, topical, 117g, single dose |
| Ivermectin 0.5% Lotion [SKLICE] | Active comparator | Drug: Ivermectin 0.5% Topical Application Lotion [SKLICE]Sklice 0.5% Lotion, topical, 117g, single dose |
| Placebo 0% Lotion | Placebo comparator | Drug: Placebo 0% Lotion0% lotion, 117g, single dose |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- 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, through the age of 18, presenting with an active head lice infestation.
- Household members that 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) will receive the Standard of Care with an over-the-counter head lice treatment product. Up to 3 infested household members may receive treatment, if more than 3 household members are infested, the entire household will be excluded from the study.
- Subject is male or female.
- Index subject is at least 6 months through 18 years of age at time of enrollment.
- Subject is in good general health based on medical history.
Key exclusion criteria (13 listed)
- Index subjects with greater than 3 household members with at least 1 live louse (adult and/or nymph) present on the scalp and/or hair, as determined by a trained evaluator will be automatically excluded from the trial.
- Youngest household member is over 18 years of age.
- History of irritation or sensitivity to ivermectin or the lotion 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 medical monitor, will interfere with safety and/or efficacy evaluations.
- Presentation at the treatment site with eczema or atopic dermatitis.
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 0.5% Topical Application LotionSubjects on Test Product will receive a single dose, 117g, during the study to be applied at baseline. | Drug | Ivermectin 0.5% Lotion |
| Ivermectin 0.5% Topical Application Lotion [SKLICE]Subjects on Reference Product will receive a single dose, 117g, during the study to be applied at baseline. | Drug | Ivermectin 0.5% Lotion [SKLICE] |
| Placebo 0% LotionSubjects on Placebo will receive a single dose, 117g, during the study to be applied at baseline. | Drug | Placebo 0% Lotion |
Primary outcome
The Proportion of Index Subjects Who Are Lice Free at Day 15
Time frame: 15 Days
The primary endpoint is the proportion of index subjects who are lice free at Day 15
1 secondary outcome
The Number of All Index Subjects Who Are Lice-free at Day 2
Time frame: 2 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 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 0.5% Topical Application Lotion and Ivermectin 0.5% Topical Application Lotion [SKLICE] in people with Head Lice, run by Mayne Pharma International Pty Ltd at 6 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 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 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 17 Sep 2020). 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?
The Proportion of Index Subjects Who Are Lice Free at Day 15 (time frame: 15 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 17 Sep 2020.