PediculosisPhase 2NCT01336647
An Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation
A Phase 2 study testing Group A - Low-Dose Ha44 0.37% w/w and Group B - High Dose Ha44 Gel 0.74% w/w in people with Pediculosis, run by Dr. Reddy's Laboratories Limited at 2 sites in United States.
Trial summary
Phase 2 study to assess the safety and effectiveness of a product to treat children and adults with head lice Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Pediculosis
- What is being tested?
- Group A - Low-Dose Ha44 0.37% w/w and Group B - High Dose Ha44 Gel 0.74% w/w
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2011to Mar 2012
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 2 years of age or older
- Body weight of at least 33 pounds
- Has an active head lice infestation at Day 0. An active infection is defined as at least 3 live lice for the index subject and at least 1 live louse for the other household members
- Belong to a household of no more than 6 members, except where additional household members are < 2 years of age
- Belong to a household with an eligible index subject between 2 and 12 years of age with active lice infestation
- Female subjects must be:
- of non-childbearing potential (no history of menstrual periods, post-hysterectomy, or, post-menopausal for at least 2 years) OR,
- 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.
Who cannot join
- Had treatment for head lice within 14 days prior to Day 0
- Has a household member(s) who is infested with lice but is not willing or not eligible for enrollment
- Has a condition or illness that, in the opinion of the Investigator, may interfere with the study results
- Has an electrocardiographic abnormality, renal disease or impaired renal function, dermatological disease on the face, scalp, ears or neck, or active ophthalmological disease, moderate or severe scleral injection with conjunctival erythema or purulent discharge or allergic or perennial rhinitis requiring chronic treatment
- Has been using hormonal contraception for less than 3 months or is pregnant or lactating
- Has received systemic corticosteroids within 7 days prior to Day 0 or planned while on study
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Universal BioPharma Research Institute, Inc.
Dinuba, California, 93618
Axis Clinical Trials
Los Angeles, California, 90036
About this study
Phase 2 study to assess the safety and effectiveness of a product to treat children and adults with head lice
- Conditions
- Pediculosis
- Being tested
- Group A - Low-Dose Ha44 0.37% w/w, Group B - High Dose Ha44 Gel 0.74% w/w, Group C - Placebo
- Medical subject headings
- Lice Infestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A - Low-Dose Ha44 0.37% w/wDrug
Low Dose Ha44 Gel applied to scalp and hair for 10 minutes
Group B - High Dose Ha44 Gel 0.74% w/wDrug
High Dose Ha44 Gel applied to scalp and hair for 10 minutes
Group C - PlaceboDrug
Placebo- vehicle Ha44 Gel without active ingredient applied to scalp and hair for 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A Low-Dose Ha44 Gel 0.37% w/w topically administered to head and scalp.Single application for 10 minutes. Receives: Drug: Group A - Low-Dose Ha44 0.37% w/w |
| Group B | Experimental | Group B High-Dose Ha44 Gel 0.74% w/w. Topically administered to hair and scalp. Single application for 10 minutes of duration. Receives: Drug: Group B - High Dose Ha44 Gel 0.74% w/w |
| Group C | Placebo comparator | Group C Placebo/ vehicle Ha44 Gel. Topically administered to hair and scalp.Single application for 10 minutes of duration. Receives: Drug: Group C - Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Are Lice Free at All Follow-up Visits (Day 1, 7 and 14) Through the Day 14 Visit
Measured: Follow up visit at days 1, 7 and 14 days
Secondary outcomes (1)
Safety and Tolerability of Ha44 Gel
The number of subjects with Treatment emergent AEs (TEAEs) related to the study medication will be reported by treatment group.
Measured: From treatment to last visit of the study at 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionAug 2011
- Study completionMar 2012
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 PediculosisStudies 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
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Miguel Restrepo, Principal investigator, Universal Biopharma Reserach Inc.Lydie Hazan, Principal investigator, Axis Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336647
- Sponsor's protocol ID
- Ha02-003
- Status last verified
- Apr 2020
- First submitted
- 14 Apr 2011
- Last updated
- 29 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation
- ClinicalTrials.gov ID
- NCT01336647
- Acronym / sponsor ID
- Ha02-003
- Conditions
- Pediculosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 18 Apr 2011 (estimated)
- Results
- Posted 19 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2 study to assess the safety and effectiveness of a product to treat children and adults 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Group A - Low-Dose Ha44 0.37% w/wGroup A Low-Dose Ha44 Gel 0.37% w/w topically administered to head and scalp.Single application for 10 minutes. |
| Group B | Experimental | Drug: Group B - High Dose Ha44 Gel 0.74% w/wGroup B High-Dose Ha44 Gel 0.74% w/w. Topically administered to hair and scalp. Single application for 10 minutes of duration. |
| Group C | Placebo comparator | Drug: Group C - PlaceboGroup C Placebo/ vehicle Ha44 Gel. Topically administered to hair and scalp.Single application for 10 minutes of duration. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 2 years of age or older
- Body weight of at least 33 pounds
- Has an active head lice infestation at Day 0. An active infection is defined as at least 3 live lice for the index subject and at least 1 live louse for the other household members
- Belong to a household of no more than 6 members, except where additional household members are < 2 years of age
- Belong to a household with an eligible index subject between 2 and 12 years of age with active lice infestation
Key exclusion criteria (8 listed)
- Had treatment for head lice within 14 days prior to Day 0
- Has a household member(s) who is infested with lice but is not willing or not eligible for enrollment
- Has a condition or illness that, in the opinion of the Investigator, may interfere with the study results
- Has an electrocardiographic abnormality, renal disease or impaired renal function, dermatological disease on the face, scalp, ears or neck, or active ophthalmological disease, moderate or severe scleral injection with conjunctival erythema or purulent discharge or allergic or perennial rhinitis requiring chronic treatment
- Has been using hormonal contraception for less than 3 months or is pregnant or lactating
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 |
|---|---|---|
| Group A - Low-Dose Ha44 0.37% w/wLow Dose Ha44 Gel applied to scalp and hair for 10 minutes | Drug | Group A |
| Group B - High Dose Ha44 Gel 0.74% w/wHigh Dose Ha44 Gel applied to scalp and hair for 10 minutes | Drug | Group B |
| Group C - PlaceboPlacebo- vehicle Ha44 Gel without active ingredient applied to scalp and hair for 10 minutes | Drug | Group C |
Primary outcome
Number of Participants Who Are Lice Free at All Follow-up Visits (Day 1, 7 and 14) Through the Day 14 Visit
Time frame: Follow up visit at days 1, 7 and 14 days
1 secondary outcome
Safety and Tolerability of Ha44 Gel
Time frame: From treatment to last visit of the study at 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pediculosis
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Lice; Head Lice
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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.
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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.
Miguel Restrepo principal investigator
Universal Biopharma Reserach Inc.
Lydie Hazan principal investigator
Axis Clinical Trials
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 Group A - Low-Dose Ha44 0.37% w/w and Group B - High Dose Ha44 Gel 0.74% w/w in people with Pediculosis, 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 8 inclusion and 8 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 29 Apr 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. 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 19 Jan 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 Participants Who Are Lice Free at All Follow-up Visits (Day 1, 7 and 14) Through the Day 14 Visit (time frame: Follow up visit at days 1, 7 and 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 29 Apr 2020.