PediculosisPhase 3NCT00963508

Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice

A Phase 3 study testing Malathion gel 0.5% and Permethrin 1% rinse (Nix Crème) in people with Pediculosis, run by Sun Pharmaceutical Industries, Inc. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an established head lice treatment. The new formulation has been evaluated in 2 previous studies of patients 2 years of age and older. Read more about this study

Who is it for?: Ages 2 years and older
Conditions the study is for: Pediculosis
What is being tested?: Malathion gel 0.5% and Permethrin 1% rinse (Nix Crème)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 403 participants
Where: 7 sitesUnited States
Study dates: Aug 2009to Mar 2010
Phase: Phase 3
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

Confirmed active head lice infestation

Who cannot join

Allergy to pediculicides or hair care products
Scalp conditions other than head lice
Previous head lice treatment within the past 4 weeks
Current antibiotic treatment

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Investigator Site
Hot Springs, Arkansas
Investigator Site
Kissimmee, Florida
Investigator Site
Miami, Florida
Investigator Site
Ormond Beach, Florida
Investigator Site
Picayune, Mississippi
Investigator Site
Sacramento, California
Investigator Site
San Antonio, Texas

Other trials in United States

About this study

Official title: A Multi-Center Phase III Study to Evaluate Malathion Gel 0.5% Formulation, for the Control of Head Lice in Pediatric Subjects and Adult Subjects With Pediculosis Capitis

Read the detailed description

This is a Phase III, multi-center, investigator-blinded, two-arm, randomized, parallel group study, evaluating the safety and efficacy of a Malathion Gel, 0.5% formulation, manufactured by Taro. The objective is to show superiority of the novel product to an active control, Nix® Crème Rinse, manufactured by Insight Pharmaceuticals.

Conditions: Pediculosis
Being tested: Malathion gel 0.5%, Permethrin 1% rinse (Nix Crème)
Keywords: Head Lice
Medical subject headings: Lice Infestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Malathion gel 0.5%Drug
Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present.
Permethrin 1% rinse (Nix Crème)Drug
Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present.

Study groups in NCT00963508
Study group	Role	What they receive
Malathion Gel	Experimental	Malathion gel 0.5% 30 minute application Receives: Drug: Malathion gel 0.5%
Nix Crème Rinse	Active comparator	Nix Crème Rinse applied to scalp for 10 minutes Receives: Drug: Permethrin 1% rinse (Nix Crème)

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Index Subjects Free of Any Lice 14 Days After Their Last Treatment in the Modified ITT (LOCF)
The primary efficacy variable was the proportion of index subjects who were considered a Treatment Success 14 days after their last treatment (Day 14 visit if only treated on Day 1, Day 21 visit if treated on Day 1 and Day 7)
Treatment Success in the Efficacy ITT (LOCF)
index subjects: 150 from 403 randomized (the youngest subject in the household that met the index case criteria (having nits and at least 3 live lice))
Measured: 3 weeks

Secondary outcomes (1)

Proportion of Subjects Who Were Considered a Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF).
The secondary efficacy variable was the proportion of subjects who were considered a Treatment Success 14 days after their first treatment.
Treatment Success in the Efficacy ITT (LOCF)
Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2009Mar 2010

First posted21 Aug 2009 (estimated)
Study startAug 2009
Primary completionMar 2010
Study completionMar 2010

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.
Publications (1)Papers the sponsor has linked to this study.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 403 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00963508
Sponsor's protocol ID: MALG-0816
Status last verified: May 2014
First submitted: 14 Aug 2009
Last updated: 13 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Meinking TL, Vicaria M, Eyerdam DH, Villar ME, Reyna S, Suarez G. A randomized, investigator-blinded, time-ranging study of the comparative efficacy of 0.5% malathion gel versus Ovide Lotion (0.5% malathion) or Nix Creme Rinse (1% permethrin) used as labeled, for the treatment of head lice. Pediatr Dermatol. 2007 Jul-Aug;24(4):405-11. doi: 10.1111/j.1525-1470.2007.00460.x.
PubMed 17845167

Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center Phase III Study to Evaluate Malathion Gel 0.5% Formulation, for the Control of Head Lice in Pediatric Subjects and Adult Subjects With Pediculosis Capitis
ClinicalTrials.gov ID: NCT00963508
Acronym / sponsor ID: MALG-0816
Conditions: Pediculosis
Keywords: Head Lice
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 403 participants (actual)
Lead sponsor: Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2009
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 21 Aug 2009 (estimated)
Results: Posted 13 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Malathion Gel	Experimental	Drug: Malathion gel 0.5%Malathion gel 0.5% 30 minute application
Nix Crème Rinse	Active comparator	Drug: Permethrin 1% rinse (Nix Crème)Nix Crème Rinse applied to scalp for 10 minutes

Who may qualify

Ages: 2 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Confirmed active head lice infestation

Key exclusion criteria (4 listed)

Allergy to pediculicides or hair care products
Scalp conditions other than head lice
Previous head lice treatment within the past 4 weeks
Current antibiotic treatment

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
Malathion gel 0.5%Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present.	Drug	Malathion Gel
Permethrin 1% rinse (Nix Crème)Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present.	Drug	Nix Crème Rinse

Primary outcome

Proportion of Index Subjects Free of Any Lice 14 Days After Their Last Treatment in the Modified ITT (LOCF)
Time frame: 3 weeks
The primary efficacy variable was the proportion of index subjects who were considered a Treatment Success 14 days after their last treatment (Day 14 visit if only treated on Day 1, Day 21 visit if treated on Day 1 and Day 7) Treatment Success in the Efficacy ITT (LOCF) index subjects: 150 from 403 randomized (the youngest subject in the household that met the index case criteria (having nits and at least 3 live lice))

1 secondary outcome

Proportion of Subjects Who Were Considered a Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF).
Time frame: 3 weeks

Results and safety

Results posted to the registry on 13 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Malathion Gel	206	196
Nix Crème Rinse	197	169

Primary outcome: Proportion of Index Subjects Free of Any Lice 14 Days After Their Last Treatment in the Modified ITT (LOCF)

Time frame: 3 weeks. Number. Unit: percentage of subjects

Measure	Malathion Gel n = 75	Nix Crème Rinse n = 75
Value	86.67	45.33

Malathion Gel vs Nix Crème Rinse: p <0.0001, t-test, 2 sided

Population analysed: Efficacy: index subjects who had at least one application of treatment mITT: treated subjects who had at least one post-treatment visit Subjects with missing efficacy data were included first LOCF and then with non-LOCF PP: subjects who complied with the protocol, completed all required visits Safety: all subjects who had at least one treatment

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 7 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Malathion Gel	0 of 206 (0%)	21 of 206 (10.2%)	Not reported
Nix Crème Rinse	0 of 197 (0%)	37 of 197 (18.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 17845167Meinking TL, Vicaria M, Eyerdam DH, Villar ME, Reyna S, Suarez G. A randomized, investigator-blinded, time-ranging study of the comparative efficacy of 0.5% malathion gel versus Ovide Lotion (0.5% malathion) or Nix Creme Rinse (1% permethrin) used as labeled, for the treatment of head lice. Pediatr Dermatol. 2007 Jul-Aug;24(4):405-11. doi: 10.1111/j.1525-1470.2007.00460.x.

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.

7 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 Malathion gel 0.5% and Permethrin 1% rinse (Nix Crème) in people with Pediculosis, run by Sun Pharmaceutical Industries, Inc. at 7 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 1 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 13 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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?

Yes. Results are posted in the registry (first posted 13 Jun 2014). 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?

Proportion of Index Subjects Free of Any Lice 14 Days After Their Last Treatment in the Modified ITT (LOCF) (time frame: 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00963508, which also lists 1 linked publication.

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 13 Jun 2014; AzTrials last refreshed its copy on 8 Nov 2026.