Head Lice InfestationPhase 2NCT02097485
Ovicidal Efficacy and Safety of Abametapir Lotion 0.74% Administered for the Treatment of Head Lice Infestation
A Phase 2 study testing Abametapir Lotion 0.74% w/w in people with Head Lice Infestation, run by Dr. Reddy's Laboratories Limited at 1 site in Australia.
Trial summary
The purpose of the study was to evaluate ovicidal efficacy of a single application of abametapir lotion 0.74% w/w intended for the treatment of head lice. 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
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- May 2014to Oct 2014
- Phase
- Phase 2
- 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
- Healthy male or female based on medical history
- Six months of age or older.
- Has an active head lice infestation with a minimum of 3 live head lice and at least 10 undamaged and unhatched head lice eggs in their hair.
- Agrees to an examination for head lice and compliance with the study procedures.
- All adult subjects must sign a written voluntary informed consent. For minors, the parent/ legal guardian agrees to the subject participating in the study as determined by the signing of an assent of informed consent.
Who cannot join
- Has scalp disease or a history of allergies or prior reactions to any head lice products.
- Has a condition that, in the opinion of the Investigator, may interfere with the study.
- Is receiving systemic or topical medication, which in the opinion of the Investigator, may compromise the integrity of the safety and/or efficacy assessments.
- Had treatment (over-the-counter (OTC) or home remedy medication) for head lice within 14 days prior to Day 0.
- Has received an investigational agent within 30 days prior to Day 0.
Trial locations and contacts
1 site in 1 country.
Australia1 site
National Head Lice Treatment Centre
Ringwood East, Victoria, 3135
About this study
Official title: A Randomised, Double-Blind, Vehicle-Controlled Study of Ovicidal Efficacy and Safety of Abametapir 0.74% Administered for the Treatment of Head Lice Infestation
The purpose of the study was to evaluate ovicidal efficacy of a single application of abametapir lotion 0.74% w/w intended for the treatment of head lice.
Read the detailed description
This was a double-blind, randomised, vehicle-controlled, parallel group study in males and females, aged three years and older with active head lice infestation. The study was designed to assess the ovicidal efficacy 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 the study site. This study used an ex vivo method of assessment for ovicidal efficacy.
- Conditions
- Head Lice Infestation
- Being tested
- Abametapir Lotion 0.74% w/w, Vehicle Lotion
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
200mL abametapir lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water.
Vehicle LotionDrug
control to abametapir: 200mL Vehicle Lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water.
| Study group | Role | What they receive |
|---|---|---|
| Abametapir Lotion 0.74% w/w | Active comparator | Topically administered to hair and scalp for 10 minutes application. Receives: Drug: Abametapir Lotion 0.74% w/w |
| Vehicle Lotion | Placebo comparator | Administered to scalp and hair for 10 minutes application. Receives: Drug: Vehicle Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Hatched Eggs Pre Treatment Relative to Post Treatment
Percentage of hatched eggs pre treatment relative to percentage of hatched eggs post treatment for the abametapir and vehicle treated eggs following 14 day incubation. The difference between post treatment percent hatching and pre-treatment percent hatching was calculated i.e. post-treatment minus pre-treatment hatching percent.
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 posted27 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2014
- Study completionOct 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Arnold, MBBS, Principal investigator, National Head Lice Treatment Centre, Ringwood East, Victoria, Australia, 3135
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097485
- Sponsor's protocol ID
- Ha03-008
- Status last verified
- Apr 2021
- First submitted
- 24 Mar 2014
- Last updated
- 11 May 2021
- 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 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Vehicle-Controlled Study of Ovicidal Efficacy and Safety of Abametapir 0.74% Administered for the Treatment of Head Lice Infestation
- ClinicalTrials.gov ID
- NCT02097485
- Acronym / sponsor ID
- Ha03-008
- Conditions
- Head Lice Infestation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 27 Mar 2014 (estimated)
- Results
- Posted 11 May 2021
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 evaluate ovicidal efficacy of a single application of abametapir lotion 0.74% w/w intended for the treatment of head lice.
Detailed description
This was a double-blind, randomised, vehicle-controlled, parallel group study in males and females, aged three years and older with active head lice infestation. The study was designed to assess the ovicidal efficacy 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 the study site. This study used an ex vivo method of assessment for ovicidal efficacy.
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/wTopically administered to hair and scalp for 10 minutes application. |
| Vehicle Lotion | Placebo comparator | Drug: Vehicle LotionAdministered to scalp and hair for 10 minutes application. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy male or female based on medical history
- Six months of age or older.
- Has an active head lice infestation with a minimum of 3 live head lice and at least 10 undamaged and unhatched head lice eggs in their hair.
- Agrees to an examination for head lice and compliance with the study procedures.
- All adult subjects must sign a written voluntary informed consent. For minors, the parent/ legal guardian agrees to the subject participating in the study as determined by the signing of an assent of informed consent.
Key exclusion criteria (5 listed)
- Has scalp disease or a history of allergies or prior reactions to any head lice products.
- Has a condition that, in the opinion of the Investigator, may interfere with the study.
- Is receiving systemic or topical medication, which in the opinion of the Investigator, may compromise the integrity of the safety and/or efficacy assessments.
- Had treatment (over-the-counter (OTC) or home remedy medication) for head lice within 14 days prior to Day 0.
- Has received an investigational agent within 30 days prior to Day 0.
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/w200mL abametapir lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water. | Drug | Abametapir Lotion 0.74% w/w |
| Vehicle Lotioncontrol to abametapir: 200mL Vehicle Lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water. | Drug | Vehicle Lotion |
Primary outcome
Percentage of Hatched Eggs Pre Treatment Relative to Post Treatment
Time frame: 14 days
Percentage of hatched eggs pre treatment relative to percentage of hatched eggs post treatment for the abametapir and vehicle treated eggs following 14 day incubation. The difference between post treatment percent hatching and pre-treatment percent hatching was calculated i.e. post-treatment minus pre-treatment hatching percent.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- 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.
Scott Arnold, MBBS principal investigator
National Head Lice Treatment Centre, Ringwood East, Victoria, Australia, 3135
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 Abametapir Lotion 0.74% w/w in people with Head Lice Infestation, run by Dr. Reddy's Laboratories Limited at 1 site in Australia.
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 5 inclusion and 5 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 11 May 2021. 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 Australia. 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?
Yes. Results are posted in the registry (first posted 11 May 2021). 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 Hatched Eggs Pre Treatment Relative to Post Treatment (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 11 May 2021.