PediculosisPhase 2/3NCT00752973

Safety and Tolerability of a Novel Malathion Formulation in Children Age 6-24 Months With Head Lice

A Phase 2/3 study testing MALG (malathion) Treatment in people with Pediculosis, run by Sun Pharmaceutical Industries, Inc. at 2 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 a previous phase II study, the safety and efficacy of a novel formulation of malathion 0.5% was evaluated in patients 2 years of age and older. Based on the results of that study, this formulation is currently in a phase III study for that population. Read more about this study

Who is it for?: Ages 6 to 24 months
Conditions the study is for: Pediculosis
What is being tested?: MALG (malathion) Treatment
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 2 sitesUnited States
Study dates: Sep 2008to Jan 2012
Phase: Phase 2/3
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 6 to 24 months
All sexes
No healthy volunteers
Child

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

2 sites in 1 country.

United States2 sites

Investigator Site
Bentonville, Arkansas
Investigator Site
Jonesboro, Arkansas

Other trials in United States

About this study

Official title: Phase II, Multi-Center, Open-Label, Safety and Tolerance Study of a Novel Malathion Formulation in Infants and Toddlers With Pediculosis Capitis

The current study will use blood markers and clinical evaluations to determine the safety and tolerability of this formulation when used in children 6-24 months of age.

Conditions: Pediculosis
Being tested: MALG (malathion) Treatment
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.

MALG (malathion) TreatmentDrug
Also called Novel malathion formulation
MALG applied for 30 minutes

Study groups in NCT00752973
Study group	Role	What they receive
Treatment arm	Experimental	MALG treatment Receives: Drug: MALG (malathion) Treatment

What is being measured

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

Participants With a Change in Cholinesterase Level at 1 Hour (Day 0).
Each patient (aged 6 - 24 months) was assessed at 1 hour (Day 0). The mean percent change (reduction) in plasma and RBC cholinesterase activity from baseline to 1 hr after application was calculated and accompanied by 95% confidence intervals.
If the half-widths of the derived confidence intervals are sufficiently narrow, it will demonstrate that any observed reductions in plasma and RBC cholinesterase activity fall within established safety guidelines.
Concentration of RBC-cholinesterase (RBC-ChE) and plasma cholinesterase were obtained at baseline, at 1 hr (Day 0) and at 24 hrs (Day 1) after the application of the treatment.
Mean percent change (reduction) = (Post treatment value - Baseline)/ Baseline x100.
Measured: Change from Baseline to 1 hour
Participants With a Change in Cholinesterase Level at 24 Hrs (1 Day).
Each patient was assessed at Day 1 and the mean percent reduction in plasma and RBC cholinesterase activity from baseline to 24 hr after application was calculated and accompanied by 95% confidence intervals.
Concentration of RBC-cholinesterase (RBC-ChE) and plasma cholinesterase were obtained at baseline, at 1 hr (Day 0) and at 24 hrs (Day 1) after the application of the treatment.
Mean percent reduction = (Post treatment value - Baseline)/ Baseline x100.
Measured: Change from baseline to 24 hrs (1 day)
Participants With the Clinical Evidence of Cholinesterase Inhibition
Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence of cholinesterase inhibition.
1. Abnormal heart rate.
2. Diarrhea or abdominal cramps.
3. Inappropriate sweating.
4. Pupillary miosis (constriction).
5. Respiratory difficulty such as chest tightness or wheezing.
One participant had wheezing as medical history which continued without increase in severity throughout the treatment.
Measured: at Baseline
Participants With the Clinical Evidence of Cholinesterase Inhibition
Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence cholinesterase inhibition :
1. Abnormal heart rate.
2. Diarrhea or abdominal cramps.
3. Inappropriate sweating.
4. Pupillary miosis (constriction).
5. Respiratory difficulty such as chest tightness or wheezing.
One participants had wheezing as medical history which continued without increase in severity throughout the treatment.
Measured: at 1 hr (Day 0)
Participants With the Clinical Evidence of Cholinesterase Inhibition
Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence of cholinesterase inhibition :
1. Abnormal heart rate.
2. Diarrhea or abdominal cramps.
3. Inappropriate sweating.
4. Pupillary miosis (constriction).
5. Respiratory difficulty such as chest tightness or wheezing.
One participants had wheezing as medical history which continued without increase in severity throughout the treatment.
Measured: at 24 hrs (Day 1)
Participants Clinically Cured of Head Lice 14 Days After Last Treatment
No live lice (including adults and nymphs) and nits at Day 7±1 and final lice assessment on either Day 14 (subjects not requiring retreatment) or Day 21 (for retreated subjects).
Measured: Day 7±1 and Day 14 or Day 21

Secondary outcomes (1)

Evaluation of the Local Safety of Malathion Gel, 0.5% Based Upon Reported Adverse Events and Observed Scalp Reactions.
To evaluate the safety of Malathion Gel, 0.5% based upon reported adverse events and observed scalp reactions. Additional safety assessments included eye Irritation.
Measured: Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments)

Timeline

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

Sep 2008Jan 2012

First posted16 Sep 2008 (estimated)
Study startSep 2008
Primary completionDec 2011
Study completionJan 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.
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 2/3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00752973
Sponsor's protocol ID: MALG-0813
Status last verified: Jul 2014
First submitted: 15 Sep 2008
Last updated: 7 Aug 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Safety, Efficacy and Preventative Effect of a Head Lice Product (X92001483) vs. Nix Creme Rinse (1% Permethrin).
Lice; Head Lice
Not yet recruiting
Comparative Study for the Evaluation of a New Medical Device Shampoo on the Treatment of Head Lice Infestation
Headlice
Not yet recruiting
Efficacy and Safetyof a Medical Device With a Physical Mode of Action (X92001919) Versus Paranix Anti-lice Shampoo.
Lice; Head Lice
Recruiting
Safety and Efficacy of Head-lice Treatments Elimax Green Lotion and Walgreens Lice Killing Shampoo
Head Lice

All Pediculosis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II, Multi-Center, Open-Label, Safety and Tolerance Study of a Novel Malathion Formulation in Infants and Toddlers With Pediculosis Capitis
ClinicalTrials.gov ID: NCT00752973
Acronym / sponsor ID: MALG-0813
Conditions: Pediculosis
Keywords: Head Lice
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Dec 2011 (actual)
Study completion: Jan 2012 (actual)
First posted: 16 Sep 2008 (estimated)
Results: Posted 3 Apr 2014

Clinical summary

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

The current study will use blood markers and clinical evaluations to determine the safety and tolerability of this formulation when used in children 6-24 months of age.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment arm	Experimental	Drug: MALG (malathion) TreatmentMALG treatment

Who may qualify

Ages: 6 to 24 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

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
MALG (malathion) TreatmentAlso: Novel malathion formulationMALG applied for 30 minutes	Drug	Treatment arm

Primary outcome

Participants With a Change in Cholinesterase Level at 1 Hour (Day 0).
Time frame: Change from Baseline to 1 hour
Each patient (aged 6 - 24 months) was assessed at 1 hour (Day 0). The mean percent change (reduction) in plasma and RBC cholinesterase activity from baseline to 1 hr after application was calculated and accompanied by 95% confidence intervals. If the half-widths of the derived confidence intervals are sufficiently narrow, it will demonstrate that any observed reductions in plasma and RBC cholinesterase activity fall within established safety guidelines. Concentration of RBC-cholinesterase (RBC-ChE) and plasma cholinesterase were obtained at baseline, at 1 hr (Day 0) and at 24 hrs (Day 1) after the application of the treatment. Mean percent change (reduction) = (Post treatment value - Baseline)/ Baseline x100.
Participants With a Change in Cholinesterase Level at 24 Hrs (1 Day).
Time frame: Change from baseline to 24 hrs (1 day)
Each patient was assessed at Day 1 and the mean percent reduction in plasma and RBC cholinesterase activity from baseline to 24 hr after application was calculated and accompanied by 95% confidence intervals. Concentration of RBC-cholinesterase (RBC-ChE) and plasma cholinesterase were obtained at baseline, at 1 hr (Day 0) and at 24 hrs (Day 1) after the application of the treatment. Mean percent reduction = (Post treatment value - Baseline)/ Baseline x100.
Participants With the Clinical Evidence of Cholinesterase Inhibition
Time frame: at Baseline
Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence of cholinesterase inhibition. 1. Abnormal heart rate. 2. Diarrhea or abdominal cramps. 3. Inappropriate sweating. 4. Pupillary miosis (constriction). 5. Respiratory difficulty such as chest tightness or wheezing. One participant had wheezing as medical history which continued without increase in severity throughout the treatment.
Participants With the Clinical Evidence of Cholinesterase Inhibition
Time frame: at 1 hr (Day 0)
Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence cholinesterase inhibition : 1. Abnormal heart rate. 2. Diarrhea or abdominal cramps. 3. Inappropriate sweating. 4. Pupillary miosis (constriction). 5. Respiratory difficulty such as chest tightness or wheezing. One participants had wheezing as medical history which continued without increase in severity throughout the treatment.
Participants With the Clinical Evidence of Cholinesterase Inhibition
Time frame: at 24 hrs (Day 1)
Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence of cholinesterase inhibition : 1. Abnormal heart rate. 2. Diarrhea or abdominal cramps. 3. Inappropriate sweating. 4. Pupillary miosis (constriction). 5. Respiratory difficulty such as chest tightness or wheezing. One participants had wheezing as medical history which continued without increase in severity throughout the treatment.
Participants Clinically Cured of Head Lice 14 Days After Last Treatment
Time frame: Day 7±1 and Day 14 or Day 21
No live lice (including adults and nymphs) and nits at Day 7±1 and final lice assessment on either Day 14 (subjects not requiring retreatment) or Day 21 (for retreated subjects).

1 secondary outcome

Evaluation of the Local Safety of Malathion Gel, 0.5% Based Upon Reported Adverse Events and Observed Scalp Reactions.
Time frame: Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments)

Results and safety

Results posted to the registry on 3 Apr 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 0.5% Treatment Arm	12	12

Primary outcome: Participants With a Change in Cholinesterase Level at 1 Hour (Day 0).

Time frame: Change from Baseline to 1 hour. Mean (95% Confidence Interval). Unit: percentage change in cholinesterase

Measure	MALG (Malathion Gel, 0.5% )Treatment Arm n = 10
Plasma	-1.8 (-3.9 to 0.4)
RBC cholinesterase	-0.5 (-3.5 to 2.6)

Population analysed: 10 subjects with obtained blood sample. subject 01-003: Study coordinator was unable to obtain blood sample post treatment at Visit 1, Day 0. subject 01-004: At Visit 1 Day 0 (post treatment), Blood sample could not be obtained even after two attempts.

Primary outcome: Participants With a Change in Cholinesterase Level at 24 Hrs (1 Day).

Time frame: Change from baseline to 24 hrs (1 day). Mean (95% Confidence Interval). Unit: percentage change in cholinesterase

Measure	MALG (Malathion Gel, 0.5% )Treatment Arm n = 11
Plasma Cholinesterase	-1.7 (-5.0 to 1.7)
RBC Cholinesterase	1.4 (-1.8 to 4.6)

Population analysed: 11 subjects with obtained blood sample. subject 01-004: At Visit 2, Day 1 Lab could not perform testing due to sample not suitable for testing. Because only 2ml blood was able to collected after multiple attempts.

Primary outcome: Participants With the Clinical Evidence of Cholinesterase Inhibition

Time frame: at Baseline. Number. Unit: percentage of participants

Measure	MALG (Malathion Gel, 0.5% )Treatment Arm n = 12
Value	8.3

Primary outcome: Participants With the Clinical Evidence of Cholinesterase Inhibition

Time frame: at 1 hr (Day 0). Number. Unit: percentage of participants

Measure	MALG (Malathion Gel, 0.5% )Treatment Arm n = 12
Value	8.3

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 22 months. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MALG Treatment Arm	0 of 12 (0%)	3 of 12 (25%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 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.

Related trials for Pediculosis

Recruiting
Safety, Efficacy and Preventative Effect of a Head Lice Product (X92001483) vs. Nix Creme Rinse (1% Permethrin).
Lice; Head Lice
Not yet recruiting
Comparative Study for the Evaluation of a New Medical Device Shampoo on the Treatment of Head Lice Infestation
Headlice
Not yet recruiting
Efficacy and Safetyof a Medical Device With a Physical Mode of Action (X92001919) Versus Paranix Anti-lice Shampoo.
Lice; Head Lice
Recruiting
Safety and Efficacy of Head-lice Treatments Elimax Green Lotion and Walgreens Lice Killing Shampoo
Head Lice

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 2/3 study testing MALG (malathion) Treatment in people with Pediculosis, run by Sun Pharmaceutical Industries, Inc. 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 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 7 Aug 2014. 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 combined 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.

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 3 Apr 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?

Participants With a Change in Cholinesterase Level at 1 Hour (Day 0). (time frame: Change from Baseline to 1 hour). The study lists 6 primary outcomes in all. 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 NCT00752973, 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 7 Aug 2014.