Lice; Head LicePhase 1NCT03257943
A Bioequivalence Study, Comparing Two Formulations of Ivermectin Lotion, 0.5%
A Phase 1 study testing Ivermectin Lotion, 0.5% and SKLICE (ivermectin) Lotion, 0.5% in people with Lice; Head Lice, run by Sun Pharmaceutical Industries, Inc. at 1 site in United States.
Trial summary
A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing Ivermectin Lotion, 0.5% Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lice; Head Lice
- What is being tested?
- 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
- 413 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2017to 18 Aug 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects 18 years of age or older must have provided IRB-approved written informed consent and sign a HIPAA authorization.
- Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.
Who cannot join
- Subjects with a history of hypersensitivity or allergy to or any component of the study product.
- Subject with history of irritation or sensitivity to pediculicides or hair care products.
Trial locations and contacts
1 site in 1 country.
United States1 site
Taro Pharmaceuticals USA Inc.
Hawthorne, New York, 10532
About this study
Official title: A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-group Study, Comparing Ivermectin Lotion, 0.5% in the Treatment of Subjects With Active Infestation With Head Lice and Their Ova
A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing Ivermectin Lotion, 0.5%
Read the detailed description
A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing Ivermectin Lotion, 0.5% to Sklice (Ivermectin) Lotion, 0.5% and both active treatment to a placebo control in the treatment of subjects with active infestation with head lice and their Ova
- Conditions
- Lice; Head Lice
- Being tested
- Ivermectin Lotion, 0.5%, SKLICE (ivermectin) Lotion, 0.5%, Vehicle of the Test product
- Medical subject headings
- Lice Infestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivermectin Lotion, 0.5%Drug
Also called ivermectin
Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.)
SKLICE (ivermectin) Lotion, 0.5%Drug
Also called ivermectin
SKLICE (ivermectin) Lotion, 0.5% (Arbor Pharmaceuticals, LLC)
Vehicle of the Test productDrug
Also called placebo
Vehicle for Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.)
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin Lotion, 0.5% | Experimental | One 10 minute application, under at-home use conditions Receives: Drug: Ivermectin Lotion, 0.5% |
| SKLICE (ivermectin) Lotion, 0.5% | Active comparator | One 10 minute application, under at-home use conditions Receives: Drug: SKLICE (ivermectin) Lotion, 0.5% |
| Vehicle of the Test product | Placebo comparator | One 10 minute application, under at-home use conditions Receives: Drug: Vehicle of the Test product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstration of Bioequivalence in proportion of index subjects who are lice free
Demonstration of Bioequivalence in proportion of index subjects who are lice free
Measured: Day 15 (14 days after application of study treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start20 Mar 2017
- Primary completion27 Jun 2017
- Study completion18 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lice; 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 413 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Catawba Research, Study chair, http://catawbaresearch.com/contact/
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257943
- Sponsor's protocol ID
- IVRL 1604
- Status last verified
- May 2018
- First submitted
- 3 May 2017
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-group Study, Comparing Ivermectin Lotion, 0.5% in the Treatment of Subjects With Active Infestation With Head Lice and Their Ova
- ClinicalTrials.gov ID
- NCT03257943
- Acronym / sponsor ID
- IVRL 1604
- Conditions
- Lice; Head Lice
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 413 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 27 Jun 2017 (actual)
- Study completion
- 18 Aug 2017 (actual)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing Ivermectin Lotion, 0.5%
Detailed description
A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing Ivermectin Lotion, 0.5% to Sklice (Ivermectin) Lotion, 0.5% and both active treatment to a placebo control in the treatment of subjects with active infestation with head lice and their Ova
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ivermectin Lotion, 0.5% | Experimental | Drug: Ivermectin Lotion, 0.5%One 10 minute application, under at-home use conditions |
| SKLICE (ivermectin) Lotion, 0.5% | Active comparator | Drug: SKLICE (ivermectin) Lotion, 0.5%One 10 minute application, under at-home use conditions |
| Vehicle of the Test product | Placebo comparator | Drug: Vehicle of the Test productOne 10 minute application, under at-home use conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects 18 years of age or older must have provided IRB-approved written informed consent and sign a HIPAA authorization.
- Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.
Key exclusion criteria (2 listed)
- Subjects with a history of hypersensitivity or allergy to or any component of the study product.
- Subject with history of irritation or sensitivity to pediculicides or hair care products.
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 Lotion, 0.5%Also: ivermectinIvermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.) | Drug | Ivermectin Lotion, 0.5% |
| SKLICE (ivermectin) Lotion, 0.5%Also: ivermectinSKLICE (ivermectin) Lotion, 0.5% (Arbor Pharmaceuticals, LLC) | Drug | SKLICE (ivermectin) Lotion, 0.5% |
| Vehicle of the Test productAlso: placeboVehicle for Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.) | Drug | Vehicle of the Test product |
Primary outcome
Demonstration of Bioequivalence in proportion of index subjects who are lice free
Time frame: Day 15 (14 days after application of study treatment)
Demonstration of Bioequivalence in proportion of index subjects who are lice free
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
- Individual participant dataSharing planned: No
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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.
Catawba Research study chair
http://catawbaresearch.com/contact/
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ivermectin Lotion, 0.5% and SKLICE (ivermectin) Lotion, 0.5% in people with Lice; Head Lice, run by Sun Pharmaceutical Industries, 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 2 inclusion and 2 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 18 May 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Demonstration of Bioequivalence in proportion of index subjects who are lice free (time frame: Day 15 (14 days after application of study treatment)). 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 18 May 2018.