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Trial record 2 of 10 for:    Malathion

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

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ClinicalTrials.gov Identifier: NCT00752973
Recruitment Status : Completed
First Posted : September 16, 2008
Results First Posted : April 3, 2014
Last Update Posted : August 7, 2014
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pediculosis
Intervention Drug: MALG (malathion) Treatment
Enrollment 12

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Malathion Gel 0.5% Treatment Arm
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Malathion Gel 0.5% treatment

MALG (Malathion Gel 0.5%) Treatment: MALG applied for 30 minutes

Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title MALG Treatment Arm
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MALG treatment

MALG (malathion) Treatment: MALG applied for 30 minutes

Overall Number of Baseline Participants 12
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[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 12 participants
17.5  (4.64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
10
  83.3%
Male
2
  16.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
9
  75.0%
More than one race
1
   8.3%
Unknown or Not Reported
2
  16.7%
1.Primary Outcome
Title Participants With a Change in Cholinesterase Level at 1 Hour (Day 0).
Hide Description

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.

Time Frame Change from Baseline to 1 hour
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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.

Arm/Group Title MALG (Malathion Gel, 0.5% )Treatment Arm
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MALG (Malathion Gel, 0.5% ) treatment

MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes

Two subjects had out of range RBC cholinesterase values. One subject had out of range (low) value at baseline and One subject had out of range (low) value 1 h post treatment. Both these values were considered to be not clinically significant by the investigator.

Overall Number of Participants Analyzed 10
Mean (95% Confidence Interval)
Unit of Measure: percentage change in cholinesterase
Plasma
-1.8
(-3.9 to 0.4)
RBC cholinesterase
-0.5
(-3.5 to 2.6)
2.Primary Outcome
Title Participants With a Change in Cholinesterase Level at 24 Hrs (1 Day).
Hide Description

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.

Time Frame Change from baseline to 24 hrs (1 day)
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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.
Arm/Group Title MALG (Malathion Gel, 0.5% )Treatment Arm
Hide Arm/Group Description:

MALG (Malathion Gel, 0.5% ) treatment

MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes

A subject had out of range (low) RBC cholinesterase value 1 h post treatment. This value was considered to be not clinically significant by the investigator.

Overall Number of Participants Analyzed 11
Mean (95% Confidence Interval)
Unit of Measure: percentage change in cholinesterase
Plasma Cholinesterase
-1.7
(-5.0 to 1.7)
RBC Cholinesterase
1.4
(-1.8 to 4.6)
3.Primary Outcome
Title Participants With the Clinical Evidence of Cholinesterase Inhibition
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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.

Time Frame at Baseline
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[Not Specified]
Arm/Group Title MALG (Malathion Gel, 0.5% )Treatment Arm
Hide Arm/Group Description:

MALG (Malathion Gel, 0.5% ) treatment

MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes

Subjects who reported signs or symptoms of cholinesterase inhibition pre treatment

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: percentage of participants
8.3
4.Primary Outcome
Title Participants With the Clinical Evidence of Cholinesterase Inhibition
Hide Description

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.

Time Frame at 1 hr (Day 0)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title MALG (Malathion Gel, 0.5% )Treatment Arm
Hide Arm/Group Description:

MALG (Malathion Gel, 0.5% ) treatment

MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes

Subjects who reported signs or symptoms of cholinesterase inhibition pre treatment

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: percentage of participants
8.3
5.Primary Outcome
Title Participants With the Clinical Evidence of Cholinesterase Inhibition
Hide Description

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.

Time Frame at 24 hrs (Day 1)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title MALG (Malathion Gel, 0.5% )Treatment Arm
Hide Arm/Group Description:

MALG (Malathion Gel, 0.5% ) treatment

MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes

Subjects who reported signs or symptoms of cholinesterase inhibition pre treatment

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: percentage of participants
0
6.Primary Outcome
Title Participants Clinically Cured of Head Lice 14 Days After Last Treatment
Hide Description 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).
Time Frame Day 7±1 and Day 14 or Day 21
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Hide Analysis Population Description
No statistical analysis provided for Clinical Cure
Arm/Group Title MALG (Malathion Gel, 0.5% )Treatment Arm
Hide Arm/Group Description:

MALG (Malathion Gel, 0.5% ) treatment

MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes

Two subjects had out of range RBC cholinesterase values. One subject had out of range (low) value at baseline and One subject had out of range (low) value 1 h post treatment. Both these values were considered to be not clinically significant by the investigator.

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants cured of lice
12
7.Secondary Outcome
Title Evaluation of the Local Safety of Malathion Gel, 0.5% Based Upon Reported Adverse Events and Observed Scalp Reactions.
Hide Description To evaluate the safety of Malathion Gel, 0.5% based upon reported adverse events and observed scalp reactions. Additional safety assessments included eye Irritation.
Time Frame Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments)
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A total of 12 subjects were enrolled. All of them used the study drug for at least one dose of the treatment. At Day 0 the study drug was to be used. At Day 7 if subject presented with live lice they were provided a second treatment. The subjects may used it for 1 (for subjects not requiring retreatment) or 2 (for retreated subjects).
Arm/Group Title MALG (Malathion Gel, 0.5% )Treatment Arm
Hide Arm/Group Description:

MALG (Malathion Gel, 0.5% ) treatment

MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes

Subjects who reported signs or symptoms of cholinesterase inhibition pre treatment

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
No sign of irritation 11
Slight noticeable erythema + slight infiltration 1
No conjunctival irritation 12
Time Frame 22 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MALG Treatment Arm
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MALG treatment

MALG (malathion) Treatment: MALG applied for 30 minutes

All-Cause Mortality
MALG Treatment Arm
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MALG Treatment Arm
Affected / at Risk (%) # Events
Total   0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
MALG Treatment Arm
Affected / at Risk (%) # Events
Total   3/12 (25.00%)    
Gastrointestinal disorders   
Diarrhoea  2  1/12 (8.33%)  1
Injury, poisoning and procedural complications   
Head injury  2  1/12 (8.33%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  3/12 (25.00%)  3
Wheezing  1  1/12 (8.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
2
Term from vocabulary, MedDRA 10.0).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Director, Clinical Research
Organization: Taro Pharmaceuticals U.S.A., Inc.
Phone: 914 345 9001
Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT00752973     History of Changes
Other Study ID Numbers: MALG-0813
First Submitted: September 15, 2008
First Posted: September 16, 2008
Results First Submitted: February 19, 2014
Results First Posted: April 3, 2014
Last Update Posted: August 7, 2014