Head Lice InfestationPhase 2NCT01907490
Safety and PK Study of Ha44 Gel Under Maximal Use Conditions for Treatment of Head Lice Infestation
A Phase 2 study testing Ha44 Gel in people with Head Lice Infestation, run by Dr. Reddy's Laboratories Limited.
Trial summary
The purpose of the study is to evaluate the safety and tolerability of a single application of Ha44 Gel 0.74% w/v for the treatment of head lice under maximal use conditions. Secondary objective is to evaluate pharmacokinetics of Ha44 and benzyl alcohol (contained in Ha44 vehicle) under maximal use conditions. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Head Lice Infestation
- What is being tested?
- Ha44 Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Dec 2013
- 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 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female
- 6 months to 17 years of age
- Be in good health, as determined by medical history and physical examination
- Has an active head lice infestation at screening as determined by an experienced evaluator. An active infestation is defined as the presence of at least 3 live lice.
- Female subjects must be:
- Of non-childbearing potential (no history of menstrual periods, post-hysterectomy, or post-menopausal for at least 2 years) OR,
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- If of childbearing potential, must have a negative urine pregnancy test prior to treatment and agree to use a highly effective method of contraception from Day 0 through the Day 14 visit. Acceptable methods of contraception include abstinence, vasectomized partner, tubal ligation, combined oral hormonal contraceptive, contraceptive injection, contraceptive patch, or IUD. If a hormonal contraception is the only method, the subject must have been on a stable dose for at least 3 months.
- The parent/guardian agrees to allow serial blood samples collected from subject for PK analysis during study.
- Has signed an informed consent and/or assent form (ICF).
Who cannot join
- Has a condition or illness that, in the opinion of the Investigator, may interfere with the study results.
- Has current dermatological disease or inflammation on the face, scalp, ears, neck or back, including eczema, atopic dermatitis, alopecia, psoriasis or any other chronic skin disease that, in the opinion of the Investigator, would interfere with the safety or PK evaluation.
- Had a prior reaction to products containing piperonyl butoxide, pyrethrin, or pyrethrum extract.
- Has been using hormonal contraception for less than 3 months.
- Is pregnant or currently nursing.
- Receiving systemic or topical medication, which in the opinion of the Investigator, may interfere with the study results.
- Has received an investigational agent within 30 days prior to Day 0.
About this study
Official title: A Safety and Pharmacokinetic Study of Ha44 Gel Administered Topically Under Maximal Use Conditions for the Treatment of Head Lice Infestation.
The purpose of the study is to evaluate the safety and tolerability of a single application of Ha44 Gel 0.74% w/v for the treatment of head lice under maximal use conditions.
Secondary objective is to evaluate pharmacokinetics of Ha44 and benzyl alcohol (contained in Ha44 vehicle) under maximal use conditions.
Read the detailed description
This is an open-label safety and pharmacokinetic (PK) study involving a single application of Ha44 Gel 0.74% administered under maximal use conditions.
All participants must have an active head lice infestation (at least 3 live lice) and be 6 months to 17 years of age. The study will enroll approximately 36 pediatric subjects between the ages of 6 months and 17 years.
Pediatric PK samples will be collected at 0 (predose), 30 and 60 mins and 2 and 8 hrs time points.
More than one household member with an active lice infestation may participate in the study. Eligible subjects will be consented and screened for study eligibility on Day 0 (Visit 1). All subjects will return to the study site for three follow-up clinic visits at Days 1, 7 and 14. The maximum study duration for a subject is 16 days.
- Conditions
- Head Lice Infestation
- Being tested
- Ha44 Gel
- Keywords
- Topical treatment of Head Lice Infestation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ha44 GelDrug
Also called Benzyl Alcohol
Eligible subjects will be treated at the study site on Day 0 with a single application of the maximum feasible amount of Ha44 Gel, to ensure saturation of the scalp and hair.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ha44 Gel 0.74%, topical solution, maximum feasible amount applied for 10 minutes Receives: Drug: Ha44 Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of the Subjects With AEs.
Safety and tolerability assessed by AEs. Number of subjects with reporting AEs.
Measured: 3 months
Secondary outcomes (3)
Pk Parameters: Cmax
Maximum concentration of Ha44 (Cmax)
Measured: 0 to 8 hours
PK Parameters: Tmax
Time to maximum concentration of Ha44 (Tmax)
Measured: 0-8 hours
PK Parameters: AUC(0-8)
Area under the concentration-time curve of Ha44 (AUC 0-8)
Measured: 0-8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startMar 2013
- Primary completionJul 2013
- Study completionDec 2013
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Accelovance, Target Health Inc.
- Responsible party
- Sponsor
- Investigators
- Srinivas Sidgiddi, MD, Study director, Dr. Reddy's Laboratories Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907490
- Sponsor's protocol ID
- Ha03-004
- Status last verified
- Apr 2020
- First submitted
- 22 Jul 2013
- Last updated
- 28 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Pharmacokinetic Study of Ha44 Gel Administered Topically Under Maximal Use Conditions for the Treatment of Head Lice Infestation.
- ClinicalTrials.gov ID
- NCT01907490
- Acronym / sponsor ID
- Ha03-004
- Conditions
- Head Lice Infestation
- Keywords
- Topical treatment of Head Lice Infestation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Accelovance, Target Health Inc.
- Study start
- Mar 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 Jul 2013 (estimated)
- Results
- Posted 9 Feb 2015
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 is to evaluate the safety and tolerability of a single application of Ha44 Gel 0.74% w/v for the treatment of head lice under maximal use conditions.
Secondary objective is to evaluate pharmacokinetics of Ha44 and benzyl alcohol (contained in Ha44 vehicle) under maximal use conditions.
Detailed description
This is an open-label safety and pharmacokinetic (PK) study involving a single application of Ha44 Gel 0.74% administered under maximal use conditions.
All participants must have an active head lice infestation (at least 3 live lice) and be 6 months to 17 years of age. The study will enroll approximately 36 pediatric subjects between the ages of 6 months and 17 years.
Pediatric PK samples will be collected at 0 (predose), 30 and 60 mins and 2 and 8 hrs time points.
More than one household member with an active lice infestation may participate in the study. Eligible subjects will be consented and screened for study eligibility on Day 0 (Visit 1). All subjects will return to the study site for three follow-up clinic visits at Days 1, 7 and 14. The maximum study duration for a subject is 16 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Ha44 GelHa44 Gel 0.74%, topical solution, maximum feasible amount applied for 10 minutes |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Male or female
- 6 months to 17 years of age
- Be in good health, as determined by medical history and physical examination
- Has an active head lice infestation at screening as determined by an experienced evaluator. An active infestation is defined as the presence of at least 3 live lice.
- Female subjects must be:
Key exclusion criteria (7 listed)
- Has a condition or illness that, in the opinion of the Investigator, may interfere with the study results.
- Has current dermatological disease or inflammation on the face, scalp, ears, neck or back, including eczema, atopic dermatitis, alopecia, psoriasis or any other chronic skin disease that, in the opinion of the Investigator, would interfere with the safety or PK evaluation.
- Had a prior reaction to products containing piperonyl butoxide, pyrethrin, or pyrethrum extract.
- Has been using hormonal contraception for less than 3 months.
- Is pregnant or currently nursing.
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 GelAlso: Benzyl AlcoholEligible subjects will be treated at the study site on Day 0 with a single application of the maximum feasible amount of Ha44 Gel, to ensure saturation of the scalp and hair. | Drug | 1 |
Primary outcome
Number of the Subjects With AEs.
Time frame: 3 months
Safety and tolerability assessed by AEs. Number of subjects with reporting AEs.
3 secondary outcomes
Pk Parameters: Cmax
Time frame: 0 to 8 hours
PK Parameters: Tmax
Time frame: 0-8 hours
PK Parameters: AUC(0-8)
Time frame: 0-8 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Srinivas Sidgiddi, MD study director
Dr. Reddy's Laboratories Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ha44 Gel in people with Head Lice Infestation, run by Dr. Reddy's Laboratories Limited.
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 9 inclusion and 7 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 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 9 Feb 2015). 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?
Number of the Subjects With AEs. (time frame: 3 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 28 Apr 2020.