Pediculosis CapitisPhase 2NCT03286101
Efficacy and Safety of Topical 0.5% Ivermectin Lotion for the Treatment of Head Lice Infestation in Filipinos
A Phase 2 study testing 0.5% Ivermectin lotion in people with Pediculosis Capitis, run by United Laboratories at 1 site in Philippines.
Trial summary
This is a randomized, double-blind, placebo-controlled clinical study evaluating the efficacy and safety of a single application of 0.5% ivermectin lotion in Filipino subjects with head lice. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pediculosis Capitis
- What is being tested?
- 0.5% Ivermectin lotion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 sitePhilippines
- Study dates
- 14 Sep 2017to 9 Nov 2017
- Phase
- Phase 2
- 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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Index subjects must have an active lice infestation defined as: At least 3 live lice (adult and/or nymphs) present on the scalp and/or hair as determined by a trained evaluator; After the index subject has been enrolled, additional infested household members 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 3 years old or older at the time of enrollment;
- Subject is in good general health based on the medical history;
- Each adult subject must have an appropriately signed Informed Consent agreement. For children, parents/guardian must sign an Informed Parental Consent agreement for children not old enough to do so. Children of a specified 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 the study. No more than one working male per household maybe 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 caregiver must be physically able and willing to report to the testing center for the supervised application of the product.
- Subjects agrees not to use any other form of lice treatment (commercial 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.
Who cannot join
- History of irritation or sensitivity to ivermectin or lotion components pediculosis or hair care products;
- Presence of visible skin / scalp conditions that are not attributable to head lice infestation, such as erythema, blisters, vesicles which in the opinion of the investigative personnel will interfere with safety and / or efficacy evaluations;
- Subjects suffering from psoriasis, atopic dermatitis or other conditions, which in the opinion of the investigator may compromise the objective of the study;
- Treatment for head lice (OTC, home remedy or Rx) in the last 14 days;
- Subjects under treatment which in the opinion of the investigator will interfere with the study results;
- Subjects who participated in a previous investigational drug study within the past 30 days;
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- Subjects who does not understand the requirements for the study participation and/ or likely exhibit poor compliance, in the opinion of the investigator;
- Females who are pregnant or lactating.
- Living in a household where at least one member is pregnant, lactating, or planning a pregnancy
- Subjects with skin lesions, specifically skin breaks are excluded because of possible absorption of the drug
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Clinical Trial Management and Testing Associates, Inc.
City of Muntinlupa
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial On The Efficacy And Safety Of Topical 0.5% Ivermectin Lotion For The Treatment Of Head Lice Infestation Among Filipino Children Age 3 Years Or Older
This is a randomized, double-blind, placebo-controlled clinical study evaluating the efficacy and safety of a single application of 0.5% ivermectin lotion in Filipino subjects with head lice.
- Conditions
- Pediculosis Capitis
- Being tested
- 0.5% Ivermectin lotion, Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% Ivermectin lotionDrug
The intervention is composed of a single application of the 0.5% ivermectin lotion.
VehicleDrug
The intervention is composed of a single application of the vehicle control.
| Study group | Role | What they receive |
|---|---|---|
| 0.5% Ivermectin Lotion | Experimental | Not described Receives: Drug: 0.5% Ivermectin lotion |
| Vehicle control | Placebo comparator | Not described Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants cured of head lice infestation from their assigned product on day 2, day 8 and day 15 after the first treatment.
Measured: Day 2 to day 15 after product application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start14 Sep 2017
- Primary completion12 Oct 2017
- Study completion9 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediculosis CapitisStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gertrude Chan, M.D., Principal investigator, Clinical Trial Management and Testing Associates, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286101
- Sponsor's protocol ID
- RD2017-01
- Status last verified
- Mar 2018
- First submitted
- 14 Sep 2017
- Last updated
- 7 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Clinical Trial On The Efficacy And Safety Of Topical 0.5% Ivermectin Lotion For The Treatment Of Head Lice Infestation Among Filipino Children Age 3 Years Or Older
- ClinicalTrials.gov ID
- NCT03286101
- Acronym / sponsor ID
- RD2017-01
- Conditions
- Pediculosis Capitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- United LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 12 Oct 2017 (actual)
- Study completion
- 9 Nov 2017 (actual)
- First posted
- 18 Sep 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.
This is a randomized, double-blind, placebo-controlled clinical study evaluating the efficacy and safety of a single application of 0.5% ivermectin lotion in Filipino subjects with head lice.
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 Lotion | Experimental | Drug: 0.5% Ivermectin lotion |
| Vehicle control | Placebo comparator | Drug: Vehicle |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Index subjects must have an active lice infestation defined as: At least 3 live lice (adult and/or nymphs) present on the scalp and/or hair as determined by a trained evaluator; After the index subject has been enrolled, additional infested household members 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 3 years old or older at the time of enrollment;
- Subject is in good general health based on the medical history;
Key exclusion criteria (10 listed)
- History of irritation or sensitivity to ivermectin or lotion components pediculosis or hair care products;
- Presence of visible skin / scalp conditions that are not attributable to head lice infestation, such as erythema, blisters, vesicles which in the opinion of the investigative personnel will interfere with safety and / or efficacy evaluations;
- Subjects suffering from psoriasis, atopic dermatitis or other conditions, which in the opinion of the investigator may compromise the objective of the study;
- Treatment for head lice (OTC, home remedy or Rx) in the last 14 days;
- Subjects under treatment which in the opinion of the investigator will interfere with the study results;
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 |
|---|---|---|
| 0.5% Ivermectin lotionThe intervention is composed of a single application of the 0.5% ivermectin lotion. | Drug | 0.5% Ivermectin Lotion |
| VehicleThe intervention is composed of a single application of the vehicle control. | Drug | Vehicle control |
Primary outcome
Proportion of participants cured of head lice infestation from their assigned product on day 2, day 8 and day 15 after the first treatment.
Time frame: Day 2 to day 15 after product application
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 7 Mar 2018.
- Individual participant dataSharing planned: No
Related trials for Pediculosis Capitis
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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
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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.
Gertrude Chan, M.D. principal investigator
Clinical Trial Management and Testing Associates, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.5% Ivermectin lotion in people with Pediculosis Capitis, run by United Laboratories at 1 site in Philippines.
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 12 inclusion and 10 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 7 Mar 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 Philippines. 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?
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?
Proportion of participants cured of head lice infestation from their assigned product on day 2, day 8 and day 15 after the first treatment. (time frame: Day 2 to day 15 after product application). 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 7 Mar 2018.