Head LicePhase 3NCT03301649
Clinical Endpoint Study of Ivermectin 0.5% Lotion
A Phase 3 study testing Generic Ivermectin Lotion 0.5% and Sklice® (Ivermectin) Lotion 0.5% in people with Head Lice, run by Actavis Inc. at 1 site in United States.
Trial summary
This clinical study is designed to evaluate the clinical (therapeutic) effect of a generic ivermectin lotion 0.5% (Actavis Laboratories UT, Inc.) relative to that of the Food and Drug Administration (FDA) Reference Listed Drug (RLD) SKLICE® (ivermectin) lotion, 0.5% (Arbor Pharmaceuticals, LLC) in participants with… Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Head Lice
- What is being tested?
- Generic Ivermectin Lotion 0.5% and Sklice® (Ivermectin) Lotion 0.5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 905 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2017to 12 Mar 2018
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Signed Institutional Review Board (IRB)-approved informed consent form that meets all criteria of current FDA regulations. For participants who are considered minors in the state the study is being conducted (<18 years in most states), the parent or legal guardian should sign the consent form and the child will be required to sign a participant "assent" form, as appropriate. Participants 11-17 years of age will read and sign an IRB-approved assent form and participants 6-10 years of age will provide verbal assent. Participants 6 months-5 years of age will be exempt from providing assent based on the child's comprehension and cognitive skills.
- The participant and/or the participant's parent (legal guardian) is willing to apply the study product as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
- Male or non-pregnant, non-lactating female, 6 months of age or older.
- Females of childbearing potential must not be pregnant or lactating at Visit 1 (Day -1 to 1) (as confirmed by a negative urine pregnancy test with a sensitivity of less than 50 milli-international units/milliliter [mIU/mL] or equivalent units of human chorionic gonadotropin). Women of childbearing potential must agree to the use of a reliable method of contraception. (for example, total abstinence, intrauterine device, a double-barrier method, oral, transdermal, injected, or implanted non-hormonal or hormonal contraceptive) throughout the study. Female participants using hormonal contraceptives should have been on the same product/dosing regimen for at least 28 days before Visit 1 (Day -1 to 1) and should not change this regimen during the study. A sterile sexual partner is not considered an adequate form of birth control.
- Index participants (that is, the youngest household member) must have an active head lice infestation, defined as ≥3 live lice (that is, live adults and/or nymphs), at Visit 1 (Day -1 to 1).
- Household members participating in the study must have ≥1 live louse (that is; live adults and/or nymphs) at Visit 1 (Day -1 to 1).
- All members of the household must be present for examination. Any male head of household who is unable to attend Visit 1 (Day -1 to 1) may be assessed by a second member of the household as being lice free.
Who cannot join
- Females who are pregnant, lactating or planning to become pregnant during the study period.
- Participants who do not have a known household affiliation with their household members (that is, do not stay in 1 household consistently, sleeping at 1 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).
- Any infested member of the household is unable or unwilling to be treated with the study product. This includes male heads of household who do not attend Visit 1 (Day -1 to 1) but report infestation with lice.
- More than 3 members of the household infested with lice.
- Presence of visible skin/scalp condition(s) or open wounds at the application site that are not attributable to head lice infestation and that in the opinion of the Investigator will interfere with safety and/or efficacy evaluations.
- Presence of eczema or atopic dermatitis at the application site.
Show all 18Show fewer
- Use of any prescription, over-the-counter, or home remedies for the treatment of head lice within 7 days before Visit 1 (Day -1 to 1).
- Use of pediculicides within 4 weeks before Visit 1 (Day -1 to 1).
- Use of systemic anti-parasitic agents within four weeks before Visit 1.
- Participants with very short (shaved) hair or who are planning to shave head during the study.
- Use of any hair dye, bleaches, hair straightening, or permanent wave solution on the hair within 14 days before Visit 1 (Day -1 to 1).
- History of allergy or sensitivity to pediculicides or hair care products.
- History of any drug hypersensitivity or intolerance that, in the opinion of the Investigator, would compromise the safety of the participant or results of the study.
- Significant history or current acute or chronic infectious disease, system disorder, Netherton's Syndrome, organ disorder (for example, hepatic or renal impairment) or insufficiency, immunosuppression (from medical treatment or disease), organ transplant, uncontrolled diabetes, uncontrolled hypertension, current ocular condition, or other medical condition that, in the Investigator's opinion, would place the study participant at undue risk by participating in the study.
- Participants or non-infested household members who would act as the primary caregiver who are of intellectually competent age but unable to understand the protocol requirements, instructions, and study-related restrictions, the nature, scope, and possible consequences of the clinical study.
- Receipt of any drug as part of a research study within 30 days before Visit 1 (Day -1 to 1).
- The participant is a member of the investigational study staff or a member of the family of the investigational study staff.
- Previous participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence and Safety of Ivermectin Lotion 0.5% (Actavis Laboratories UT, Inc.) to SKLICE® (Ivermectin) Lotion, 0.5% (Arbor Pharmaceuticals, LLC) in the Treatment of Human Head Lice Infestation
This clinical study is designed to evaluate the clinical (therapeutic) effect of a generic ivermectin lotion 0.5% (Actavis Laboratories UT, Inc.) relative to that of the Food and Drug Administration (FDA) Reference Listed Drug (RLD) SKLICE® (ivermectin) lotion, 0.5% (Arbor Pharmaceuticals, LLC) in participants with active head lice infestation. Additionally, both the test and reference (that is; the RLD) treatments were tested for superiority to a placebo.
Read the detailed description
Participants will be randomized by household in a 3:3:1 ratio to receive generic ivermectin lotion 0.5%, Sklice (ivermectin) lotion 0.5%, or vehicle lotion.
- Conditions
- Head Lice
- Being tested
- Generic Ivermectin Lotion 0.5%, Sklice® (Ivermectin) Lotion 0.5%, Vehicle Lotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generic Ivermectin Lotion 0.5%Drug
Topical lotion, generic formulation of the brand product.
Sklice® (Ivermectin) Lotion 0.5%Drug
Topical lotion, brand product.
Vehicle LotionDrug
Topical lotion, placebo. Has no active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Generic Ivermectin Lotion 0.5% | Experimental | Infested household participants will administer a single application of up to 117 grams (1 tube) of generic ivermectin 0.5% topical lotion to the dry hair (avoiding contact with eyes) at home on Day 1, leave the lotion on the hair and scalp for 10 minutes, and then rinse off with warm water. Participants will be instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel is permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants are not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit has been completed. Receives: Drug: Generic Ivermectin Lotion 0.5% |
| Sklice (Ivermectin) Lotion 0.5% | Active comparator | Infested household participants will administer a single application of up to 117 grams (1 tube) of Sklice ivermectin 0.5% topical lotion to the dry hair (avoiding contact with eyes) at home on Day 1, leave the lotion on the hair and scalp for 10 minutes, and then rinse off with warm water. Participants will be instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel is permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants are not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit has been completed. Receives: Drug: Sklice® (Ivermectin) Lotion 0.5% |
| Vehicle Lotion | Placebo comparator | Infested household participants will administer a single application of up to 117 grams (1 tube) of vehicle topical lotion to the dry hair (avoiding contact with eyes) at home on Day 1, leave the lotion on the hair and scalp for 10 minutes, and then rinse off with warm water. Participants will be instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel is permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants are not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit has been completed. Receives: Drug: Vehicle Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Index Participants Who Were Considered a Treatment Success: PP Population
Treatment success was defined as the absence of live lice. Index participant was defined as the youngest household member who was randomized into the study. Therapeutic equivalence evaluation between test (generic ivermectin lotion 0.5%) and reference groups (Sklice [ivermectin] lotion 0.5%) was done in this endpoint, hence placebo group was not included.
Measured: Day 15 ± 2
Percentage of Index Participants Who Were Considered a Treatment Success: mITT Population
Treatment success was defined as the absence of live lice. Index participant was defined as the youngest household member who was randomized into the study.
Measured: Day 15 ± 2
Secondary outcomes (2)
Percentage of All Randomized (Index + Non-Index) Participants Who Were Considered a Treatment Success: PP Population
Treatment success was defined as the absence of live lice. Non-index participant: Any household member who agreed to participate in the study but was not the youngest household member. Index participant: The youngest household member who was randomized into the study. Therapeutic equivalence evaluation between test (generic ivermectin lotion 0.5%) and reference groups (Sklice [ivermectin] lotion 0.5%) was done in this endpoint, hence placebo group was not included.
Measured: Day 15 ± 2
Percentage of All Randomized (Index + Non-Index) Participants Who Were Considered a Treatment Success: mITT Population
Treatment success was defined as the absence of live lice. Non-index participant: Any household member who agreed to participate in the study but was not the youngest household member. Index participant: The youngest household member who was randomized into the study.
Measured: Day 15 ± 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start7 Oct 2017
- Primary completion12 Mar 2018
- Study completion12 Mar 2018
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 905 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Teva Pharmaceuticals USA
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Actavis Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301649
- Sponsor's protocol ID
- 71691702
- Status last verified
- Dec 2019
- First submitted
- 1 Aug 2017
- Last updated
- 20 Dec 2019
- 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 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence and Safety of Ivermectin Lotion 0.5% (Actavis Laboratories UT, Inc.) to SKLICE® (Ivermectin) Lotion, 0.5% (Arbor Pharmaceuticals, LLC) in the Treatment of Human Head Lice Infestation
- ClinicalTrials.gov ID
- NCT03301649
- Acronym / sponsor ID
- 71691702
- Conditions
- Head Lice
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 905 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Collaborators
- Teva Pharmaceuticals USA
- Study start
- 7 Oct 2017 (actual)
- Primary completion
- 12 Mar 2018 (actual)
- Study completion
- 12 Mar 2018 (actual)
- First posted
- 4 Oct 2017 (actual)
- Results
- Posted 20 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study is designed to evaluate the clinical (therapeutic) effect of a generic ivermectin lotion 0.5% (Actavis Laboratories UT, Inc.) relative to that of the Food and Drug Administration (FDA) Reference Listed Drug (RLD) SKLICE® (ivermectin) lotion, 0.5% (Arbor Pharmaceuticals, LLC) in participants with active head lice infestation. Additionally, both the test and reference (that is; the RLD) treatments were tested for superiority to a placebo.
Detailed description
Participants will be randomized by household in a 3:3:1 ratio to receive generic ivermectin lotion 0.5%, Sklice (ivermectin) lotion 0.5%, or vehicle lotion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Generic Ivermectin Lotion 0.5% | Experimental | Drug: Generic Ivermectin Lotion 0.5%Infested household participants will administer a single application of up to 117 grams (1 tube) of generic ivermectin 0.5% topical lotion to the dry hair (avoiding contact with eyes) at home on Day 1, leave the lotion on the hair and scalp for 10 minutes, and then rinse off with warm water. Participants will be instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel is permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants are not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit has been completed. |
| Sklice (Ivermectin) Lotion 0.5% | Active comparator | Drug: Sklice® (Ivermectin) Lotion 0.5%Infested household participants will administer a single application of up to 117 grams (1 tube) of Sklice ivermectin 0.5% topical lotion to the dry hair (avoiding contact with eyes) at home on Day 1, leave the lotion on the hair and scalp for 10 minutes, and then rinse off with warm water. Participants will be instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel is permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants are not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit has been completed. |
| Vehicle Lotion | Placebo comparator | Drug: Vehicle LotionInfested household participants will administer a single application of up to 117 grams (1 tube) of vehicle topical lotion to the dry hair (avoiding contact with eyes) at home on Day 1, leave the lotion on the hair and scalp for 10 minutes, and then rinse off with warm water. Participants will be instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel is permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants are not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit has been completed. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Signed Institutional Review Board (IRB)-approved informed consent form that meets all criteria of current FDA regulations. For participants who are considered minors in the state the study is being conducted (<18 years in most states), the parent or legal guardian should sign the consent form and the child will be required to sign a participant "assent" form, as appropriate. Participants 11-17 years of age will read and sign an IRB-approved assent form and participants 6-10 years of age will provide verbal assent. Participants 6 months-5 years of age will be exempt from providing assent based on the child's comprehension and cognitive skills.
- The participant and/or the participant's parent (legal guardian) is willing to apply the study product as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
- Male or non-pregnant, non-lactating female, 6 months of age or older.
- Females of childbearing potential must not be pregnant or lactating at Visit 1 (Day -1 to 1) (as confirmed by a negative urine pregnancy test with a sensitivity of less than 50 milli-international units/milliliter [mIU/mL] or equivalent units of human chorionic gonadotropin). Women of childbearing potential must agree to the use of a reliable method of contraception. (for example, total abstinence, intrauterine device, a double-barrier method, oral, transdermal, injected, or implanted non-hormonal or hormonal contraceptive) throughout the study. Female participants using hormonal contraceptives should have been on the same product/dosing regimen for at least 28 days before Visit 1 (Day -1 to 1) and should not change this regimen during the study. A sterile sexual partner is not considered an adequate form of birth control.
- Index participants (that is, the youngest household member) must have an active head lice infestation, defined as ≥3 live lice (that is, live adults and/or nymphs), at Visit 1 (Day -1 to 1).
Key exclusion criteria (18 listed)
- Females who are pregnant, lactating or planning to become pregnant during the study period.
- Participants who do not have a known household affiliation with their household members (that is, do not stay in 1 household consistently, sleeping at 1 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).
- Any infested member of the household is unable or unwilling to be treated with the study product. This includes male heads of household who do not attend Visit 1 (Day -1 to 1) but report infestation with lice.
- More than 3 members of the household infested with lice.
- Presence of visible skin/scalp condition(s) or open wounds at the application site that are not attributable to head lice infestation and that in the opinion of the Investigator will interfere with 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 |
|---|---|---|
| Generic Ivermectin Lotion 0.5%Topical lotion, generic formulation of the brand product. | Drug | Generic Ivermectin Lotion 0.5% |
| Sklice® (Ivermectin) Lotion 0.5%Topical lotion, brand product. | Drug | Sklice (Ivermectin) Lotion 0.5% |
| Vehicle LotionTopical lotion, placebo. Has no active ingredient. | Drug | Vehicle Lotion |
Primary outcome
Percentage of Index Participants Who Were Considered a Treatment Success: PP Population
Time frame: Day 15 ± 2
Treatment success was defined as the absence of live lice. Index participant was defined as the youngest household member who was randomized into the study. Therapeutic equivalence evaluation between test (generic ivermectin lotion 0.5%) and reference groups (Sklice [ivermectin] lotion 0.5%) was done in this endpoint, hence placebo group was not included.
Percentage of Index Participants Who Were Considered a Treatment Success: mITT Population
Time frame: Day 15 ± 2
Treatment success was defined as the absence of live lice. Index participant was defined as the youngest household member who was randomized into the study.
2 secondary outcomes
Percentage of All Randomized (Index + Non-Index) Participants Who Were Considered a Treatment Success: PP Population
Time frame: Day 15 ± 2
Percentage of All Randomized (Index + Non-Index) Participants Who Were Considered a Treatment Success: mITT Population
Time frame: Day 15 ± 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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.
Study Director study director
Actavis Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Generic Ivermectin Lotion 0.5% and Sklice® (Ivermectin) Lotion 0.5% in people with Head Lice, run by Actavis 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 18 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 20 Dec 2019. 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 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 20 Dec 2019). 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 Considered a Treatment Success: PP Population (time frame: Day 15 ± 2). The study lists 2 primary outcomes in all. 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 20 Dec 2019; AzTrials last refreshed its copy on 2 Nov 2026.