Head Lice InfestationPhase 2NCT02010333
A Pediatric Safety and Pharmacokinetics Study of Ha44 Gel Administered Topically for Treatment of Head Lice Infestation
A Phase 2 study testing Ha44 Gel 0.74% w/w in people with Head Lice Infestation, run by Dr. Reddy's Laboratories Limited at 2 sites in United States.
Trial summary
The primary purpose of the study is to evaluate safety and tolerability of a single application of Ha44 Gel 0.74% w/w for the treatment of head lice. Secondary purpose is to evaluate PK of Ha44 and benzyl alcohol under conditions of maximal exposure in pediatric population. Read more about this study
- Who is it for?
- Ages 6 months to 2 years
- Conditions the study is for
- Head Lice Infestation
- What is being tested?
- Ha44 Gel 0.74% w/w
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2013to Aug 2014
- 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 6 months to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female, 6months < 3years of age
- Good health
- Active head lice infestation defined as the presence of at least 3 live lice
- Dermatological condition of scalp (at least G2 erythema or pruritus with evidence of excoriation/inflammation)
- Parent/guardian agrees to allow PK samples collected
- Signed Informed Consent Form
Who cannot join
- Condition or illness that in the opinion of the investigator may interfere with the study results.
- Current dermatological disease that may compromise the health of subject or the assessment of safety. Subjects with scalp ulceration or evidence of scalp infection should not be enrolled.
- Prior reaction to product containing piperonyl butoxide, pyrethrin, or pyrethrum extract.
- Receiving systemic or topical medication that may interfere the study results.
- Received an investigational agent within 30 days prior to Day 0.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Universal Biopharma Research Institute
Dinuba, California, 93618
Axis Clinical Trials
Los Angeles, California, 90036
About this study
Official title: A Pediatric Safety and Pharmacokinetic Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation
The primary purpose of the study is to evaluate safety and tolerability of a single application of Ha44 Gel 0.74% w/w for the treatment of head lice. Secondary purpose is to evaluate PK of Ha44 and benzyl alcohol under conditions of maximal exposure in pediatric population.
- Conditions
- Head Lice Infestation
- Being tested
- Ha44 Gel 0.74% w/w
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ha44 Gel 0.74% w/wDrug
Also called Abametapir 0.74%, Benzyl Alcohol
HA44 Gel 0.74% comprises of Abametapir as the active pharmaceutical ingredient and Benzyl Alcohol as one of the excipients.
| Study group | Role | What they receive |
|---|---|---|
| Ha44 Gel 0.74% w/w | Experimental | Open label, one arm Receives: Drug: Ha44 Gel 0.74% w/w |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of Ha44 Gel
Clinically significant changes in Physical Examinations, vital signs, safety laboratory tests and assessments of scalp and eye irritation and Electrocardiogram. The frequency and severity of Adverse Events.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010333
- Sponsor's protocol ID
- Ha03-003
- Status last verified
- May 2020
- First submitted
- 9 Dec 2013
- Last updated
- 12 May 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pediatric Safety and Pharmacokinetic Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation
- ClinicalTrials.gov ID
- NCT02010333
- Acronym / sponsor ID
- Ha03-003
- Conditions
- Head Lice Infestation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 12 Dec 2013 (estimated)
- 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.
The primary purpose of the study is to evaluate safety and tolerability of a single application of Ha44 Gel 0.74% w/w for the treatment of head lice. Secondary purpose is to evaluate PK of Ha44 and benzyl alcohol under conditions of maximal exposure in pediatric population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ha44 Gel 0.74% w/w | Experimental | Drug: Ha44 Gel 0.74% w/wOpen label, one arm |
Who may qualify
- Ages
- 6 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male or female, 6months < 3years of age
- Good health
- Active head lice infestation defined as the presence of at least 3 live lice
- Dermatological condition of scalp (at least G2 erythema or pruritus with evidence of excoriation/inflammation)
- Parent/guardian agrees to allow PK samples collected
Key exclusion criteria (5 listed)
- Condition or illness that in the opinion of the investigator may interfere with the study results.
- Current dermatological disease that may compromise the health of subject or the assessment of safety. Subjects with scalp ulceration or evidence of scalp infection should not be enrolled.
- Prior reaction to product containing piperonyl butoxide, pyrethrin, or pyrethrum extract.
- Receiving systemic or topical medication that may interfere the study results.
- 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 |
|---|---|---|
| Ha44 Gel 0.74% w/wAlso: Abametapir 0.74%, Benzyl AlcoholHA44 Gel 0.74% comprises of Abametapir as the active pharmaceutical ingredient and Benzyl Alcohol as one of the excipients. | Drug | Ha44 Gel 0.74% w/w |
Primary outcome
Safety and tolerability of Ha44 Gel
Time frame: 8 months
Clinically significant changes in Physical Examinations, vital signs, safety laboratory tests and assessments of scalp and eye irritation and Electrocardiogram. The frequency and severity of Adverse Events.
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 12 May 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ha44 Gel 0.74% w/w in people with Head Lice Infestation, run by Dr. Reddy's Laboratories Limited at 2 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 6 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 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
Safety and tolerability of Ha44 Gel (time frame: 8 months). 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 12 May 2020.