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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 Description
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Brief 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.

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.


Condition or disease Intervention/treatment Phase
Pediculosis Drug: MALG (malathion) Treatment Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II, Multi-Center, Open-Label, Safety and Tolerance Study of a Novel Malathion Formulation in Infants and Toddlers With Pediculosis Capitis
Study Start Date : September 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Malathion

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment arm
MALG treatment
 Drug: MALG (malathion) Treatment
MALG applied for 30 minutes
Other Name: Novel malathion formulation


Outcome Measures
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Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.


  5. 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.


  6. 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).


Secondary Outcome Measures :
  1. 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) ]
    To evaluate the safety of Malathion Gel, 0.5% based upon reported adverse events and observed scalp reactions. Additional safety assessments included eye Irritation.


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed active head lice infestation

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00752973


Locations
United States, Arkansas
Investigator Site
Bentonville, Arkansas, United States
Investigator Site
Jonesboro, Arkansas, United States
Sponsors and Collaborators
Taro Pharmaceuticals USA
More Information
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Publications of Results:

Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT00752973     History of Changes
Other Study ID Numbers: MALG-0813
First Posted: September 16, 2008    Key Record Dates
Results First Posted: April 3, 2014
Last Update Posted: August 7, 2014
Last Verified: July 2014

Keywords provided by Taro Pharmaceuticals USA:
Head Lice

Additional relevant MeSH terms:
Lice Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
Skin Diseases, Infectious
Skin Diseases
Malathion
 Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs