Head Lice InfestationPhase 3NCT02060903
A Study of the Efficacy and Safety of Abametapir Lotion Administered for the Treatment of Head Lice Infestation
A Phase 3 study testing Abametapir Lotion 0.74% w/w in people with Head Lice Infestation, run by Dr. Reddy's Laboratories Limited at 7 sites in United States.
Trial summary
The purpose of the study was to assess the efficacy, safety and tolerability of a single application of abametapir lotion 0.74% w/w compared to a vehicle control, when applied to the scalp and hair for 10 minutes at home. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Head Lice Infestation
- What is being tested?
- Abametapir Lotion 0.74% w/w
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 379 participants
- Where
- 7 sitesUnited States
- Study dates
- Feb 2014to Aug 2014
- 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
- Male or female, aged six months of age or older.
- Is in good general health based on medical history.
- Has active head lice infestation at Screening as determined by a trained evaluator with the exception of the male head of household who may self-assess as being lice-free. Active head lice infestation is defined as at least three live lice for the index subject and at least one live louse for the other household members.
- The subject and/or their caregiver is physically able and willing to apply the Investigational Product at home.
- Belongs to a household with an eligible index subject with active head lice infestation.
- Agrees to an examination for head lice and to all visits and procedures throughout the study.
- Has signed an informed consent and/or assent form.
Who cannot join
- Had treatment (over-the-counter ), home remedy or prescription medication) for head lice within 14 days prior to Day 0.
- Intends to use any other form of lice treatment from Day 0 through the Day 14 visit, unless provided as rescue therapy to this Protocol.
- Intends to use a lice comb from the Day 0 through the Day 14 visit unless provided as rescue therapy to this Protocol.
- Intends to cut their hair, use hair dye/bleach or have permanent wave hairstyling from Day 0 through the Day 14 visit.
- Has a household member(s) who is infested with lice but is not willing or not eligible for enrollment.
- Has a condition that, in the opinion of the Investigator, may increase the risk to the subject and/or the interpretation of the data.
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- Has 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.
- Has eczema or atopic dermatitis of skin/scalp.
- Has had a prior reaction to Nix® or products containing permethrin.
- Receiving systemic or topical medication, which in the opinion of the Investigator, may compromise the integrity of the safety and/or efficacy assessments.
- Has received an investigational agent within 30 days prior to Day 0.
- Does not have a known household affiliation with the household members (i.e., does not stay in one household consistently, or sleeps at one place for several nights and then at another place or location).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Haber Dermatology
Beachwood, Ohio, 44122
Universal Biopharma Reserach INC
Dinuba, California, 93618
Impact Clinical Trials
Las Vegas, Nevada, 89106
Axis Clinical Trials
Los Angeles, California, 90036
McKenzie Medical Center
McKenzie, Tennessee, 38201
Radiant reserach Inc.
San Antonio, Texas, 78229
LSRN Reserach
West Palm Beach, Florida, 33407
About this study
Official title: A Randomized, Double-Blind, Multicenter, Vehicle-Controlled Study of the Efficacy and Safety of Abametapir Lotion 0.74% Administered for the Treatment of Head Lice Infestation
The purpose of the study was to assess the efficacy, safety and tolerability of a single application of abametapir lotion 0.74% w/w compared to a vehicle control, when applied to the scalp and hair for 10 minutes at home.
Read the detailed description
This was a randomized, double-blind, multicenter, vehicle-controlled, parallel-group study in subjects with active head lice infestation. The study was designed to assess the efficacy, safety and tolerability of a single application of abametapir lotion 0.74% w/w compared to a vehicle control, when applied to scalp and hair for 10 minutes at home.
Approximately 106 index subjects with their household members were enrolled into the study. A total of approximately 318 subjects were enrolled, assuming an average of 3 members per household participating in the study.
- Conditions
- Head Lice Infestation
- Being tested
- Abametapir Lotion 0.74% w/w, Vehicle Lotion
- Keywords
- Head Lice, Hatchtech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abametapir Lotion 0.74% w/wDrug
Also called Abametapir 0.74%
Abametapir Lotion 0.74% was dispensed to subjects on Day 0 for self-administration at home on the same day.
Vehicle LotionDrug
Also called Vehicle
Vehicle Lotion was dispensed to subjects on Day 0 for self-administration at home on the same day.
| Study group | Role | What they receive |
|---|---|---|
| Abametapir Lotion 0.74% w/w | Active comparator | Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver. Receives: Drug: Abametapir Lotion 0.74% w/w |
| Vehicle Lotion | Placebo comparator | Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver. Receives: Drug: Vehicle Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Index Subjects Who Are Lice-free at All Follow-up Visits Through to the Day 14 Visit.
Proportion of index subjects randomized into the study who are lice free at all follow up visits through to the Day 14 visit. The index subject of a household was the youngest person within that household with at least 3 live lice present, as assessed over a period of up to 15 minutes at the Screening Visit.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
- Study completionAug 2014
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 Lice InfestationStudies 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
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Accelovance, Syneos Health
- Responsible party
- Sponsor
- Investigators
- Srinivas Sidgiddi, MD, Study director, Dr. Reddy's Laboratories Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060903
- Sponsor's protocol ID
- Ha03-001
- Status last verified
- Sep 2020
- First submitted
- 11 Feb 2014
- Last updated
- 23 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multicenter, Vehicle-Controlled Study of the Efficacy and Safety of Abametapir Lotion 0.74% Administered for the Treatment of Head Lice Infestation
- ClinicalTrials.gov ID
- NCT02060903
- Acronym / sponsor ID
- Ha03-001
- Conditions
- Head Lice Infestation
- Keywords
- Head Lice, Hatchtech
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Accelovance, Syneos Health
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 12 Feb 2014 (estimated)
- Results
- Posted 23 Sep 2020
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 the study was to assess the efficacy, safety and tolerability of a single application of abametapir lotion 0.74% w/w compared to a vehicle control, when applied to the scalp and hair for 10 minutes at home.
Detailed description
This was a randomized, double-blind, multicenter, vehicle-controlled, parallel-group study in subjects with active head lice infestation. The study was designed to assess the efficacy, safety and tolerability of a single application of abametapir lotion 0.74% w/w compared to a vehicle control, when applied to scalp and hair for 10 minutes at home.
Approximately 106 index subjects with their household members were enrolled into the study. A total of approximately 318 subjects were enrolled, assuming an average of 3 members per household participating in the study.
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 |
|---|---|---|
| Abametapir Lotion 0.74% w/w | Active comparator | Drug: Abametapir Lotion 0.74% w/wSingle topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver. |
| Vehicle Lotion | Placebo comparator | Drug: Vehicle LotionSingle topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, aged six months of age or older.
- Is in good general health based on medical history.
- Has active head lice infestation at Screening as determined by a trained evaluator with the exception of the male head of household who may self-assess as being lice-free. Active head lice infestation is defined as at least three live lice for the index subject and at least one live louse for the other household members.
- The subject and/or their caregiver is physically able and willing to apply the Investigational Product at home.
- Belongs to a household with an eligible index subject with active head lice infestation.
Key exclusion criteria (12 listed)
- Had treatment (over-the-counter ), home remedy or prescription medication) for head lice within 14 days prior to Day 0.
- Intends to use any other form of lice treatment from Day 0 through the Day 14 visit, unless provided as rescue therapy to this Protocol.
- Intends to use a lice comb from the Day 0 through the Day 14 visit unless provided as rescue therapy to this Protocol.
- Intends to cut their hair, use hair dye/bleach or have permanent wave hairstyling from Day 0 through the Day 14 visit.
- Has a household member(s) who is infested with lice but is not willing or not eligible for enrollment.
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 |
|---|---|---|
| Abametapir Lotion 0.74% w/wAlso: Abametapir 0.74%Abametapir Lotion 0.74% was dispensed to subjects on Day 0 for self-administration at home on the same day. | Drug | Abametapir Lotion 0.74% w/w |
| Vehicle LotionAlso: VehicleVehicle Lotion was dispensed to subjects on Day 0 for self-administration at home on the same day. | Drug | Vehicle Lotion |
Primary outcome
Proportion of Index Subjects Who Are Lice-free at All Follow-up Visits Through to the Day 14 Visit.
Time frame: 14 days
Proportion of index subjects randomized into the study who are lice free at all follow up visits through to the Day 14 visit. The index subject of a household was the youngest person within that household with at least 3 live lice present, as assessed over a period of up to 15 minutes at the Screening Visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 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.
Srinivas Sidgiddi, MD study director
Dr. Reddy's Laboratories Inc.
7 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 Abametapir Lotion 0.74% w/w in people with Head Lice Infestation, run by Dr. Reddy's Laboratories Limited at 7 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 7 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 23 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 7 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 23 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?
Proportion of Index Subjects Who Are Lice-free at All Follow-up Visits Through to the Day 14 Visit. (time frame: 14 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 23 Sep 2020.