Lice InfestationsPhase 3NCT00244439
Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice
A Phase 3 study testing MALG, Ovide (malathion) lotion 0.05% and Permethrin 1% in people with Lice Infestations, run by Sun Pharmaceutical Industries, Inc. at 6 sites in United States.
Trial summary
Current treatments for head lice include over-the-counter products such as permethrin and prescription products such as OVIDE (malathion 0.5%) lotion. In a previous phase II study, a novel, easy-to-use malathion 0.5% formulation was found to be a safe treatment for head lice. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Lice Infestations
- What is being tested?
- MALG, Ovide (malathion) lotion 0.05% and Permethrin 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 6 sitesUnited States
- Study dates
- Dec 2005to Dec 2006
- Phase
- Phase 3
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed active head lice infestation
- Patient, parent or guardian must be able to apply the treatment
- Entire household must be screened
- All infested persons must agree to participate
Who cannot join
- Allergy to pediculicides, hair care products or chrysanthemums
- Scalp conditions other than head lice
- Previous head lice treatment within the past 4 weeks
- Female patients who are pregnant or nursing
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Investigator Site
Miami, Florida
Investigator Site
Miamiville, Ohio
Investigator Site
New York, New York
Investigator Site
Scottsdale, Arizona
Investigator Site
St. Petersburg, Florida
Investigator Site
West Palm Beach, Florida
About this study
Official title: A Multi-Center Phase III Study to Evaluate MALG, a Novel Malathion 0.05%Formulation, for the Control of Head Lice in Pediatric and Adult Subjects With Pediculosis Capitis
Current treatments for head lice include over-the-counter products such as permethrin and prescription products such as OVIDE (malathion 0.5%) lotion. In a previous phase II study, a novel, easy-to-use malathion 0.5% formulation was found to be a safe treatment for head lice. The current study will compare the efficacy and safety of this novel formulation of malathion with OVIDE and with an over-the-counter permethrin product.
- Conditions
- Lice Infestations
- Being tested
- MALG, Ovide (malathion) lotion 0.05%, Permethrin 1%
- Keywords
- Head Lice, Pediculosis capitis
- Medical subject headings
- Lice Infestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MALGDrug
30 minute application
Ovide (malathion) lotion 0.05%Drug
8-12 hour application
Permethrin 1%Drug
10 minute application
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MALG Receives: Drug: MALG |
| 2 | Active comparator | Ovide Receives: Drug: Ovide (malathion) lotion 0.05% |
| 3 | Active comparator | Permethrin 1% Receives: Drug: Permethrin 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure of Head Lice
Measured: 4 weeks
Secondary outcomes (1)
Safety of treatments
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2005 (estimated)
- Study startDec 2005
- Primary completionOct 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lice InfestationsStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00244439
- Sponsor's protocol ID
- MALG-0506
- Status last verified
- Nov 2013
- First submitted
- 24 Oct 2005
- Last updated
- 23 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Phase III Study to Evaluate MALG, a Novel Malathion 0.05%Formulation, for the Control of Head Lice in Pediatric and Adult Subjects With Pediculosis Capitis
- ClinicalTrials.gov ID
- NCT00244439
- Acronym / sponsor ID
- MALG-0506
- Conditions
- Lice Infestations
- Keywords
- Head Lice, Pediculosis capitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 26 Oct 2005 (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.
Current treatments for head lice include over-the-counter products such as permethrin and prescription products such as OVIDE (malathion 0.5%) lotion. In a previous phase II study, a novel, easy-to-use malathion 0.5% formulation was found to be a safe treatment for head lice. The current study will compare the efficacy and safety of this novel formulation of malathion with OVIDE and with an over-the-counter permethrin product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MALGMALG |
| 2 | Active comparator | Drug: Ovide (malathion) lotion 0.05%Ovide |
| 3 | Active comparator | Drug: Permethrin 1%Permethrin 1% |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed active head lice infestation
- Patient, parent or guardian must be able to apply the treatment
- Entire household must be screened
- All infested persons must agree to participate
Key exclusion criteria (4 listed)
- Allergy to pediculicides, hair care products or chrysanthemums
- Scalp conditions other than head lice
- Previous head lice treatment within the past 4 weeks
- Female patients who are pregnant or 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 |
|---|---|---|
| MALG30 minute application | Drug | 1 |
| Ovide (malathion) lotion 0.05%8-12 hour application | Drug | 2 |
| Permethrin 1%10 minute application | Drug | 3 |
Primary outcome
Cure of Head Lice
Time frame: 4 weeks
1 secondary outcome
Safety of treatments
Time frame: 4 weeks
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 23 Dec 2013.
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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.
6 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 MALG, Ovide (malathion) lotion 0.05% and Permethrin 1% in people with Lice Infestations, run by Sun Pharmaceutical Industries, Inc. at 6 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 4 inclusion and 4 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 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 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?
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?
Cure of Head Lice (time frame: 4 weeks). 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 Dec 2013.