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

Primary Purpose

Pediculosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MALG (malathion) Treatment
Sponsored by
Taro Pharmaceuticals USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediculosis focused on measuring Head Lice

Eligibility Criteria

6 Months - 24 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigator Site
  • Investigator Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment arm

Arm Description

MALG treatment

Outcomes

Primary Outcome Measures

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.
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.
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. Abnormal heart rate. Diarrhea or abdominal cramps. Inappropriate sweating. Pupillary miosis (constriction). 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
Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence cholinesterase inhibition : Abnormal heart rate. Diarrhea or abdominal cramps. Inappropriate sweating. Pupillary miosis (constriction). 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
Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence of cholinesterase inhibition : Abnormal heart rate. Diarrhea or abdominal cramps. Inappropriate sweating. Pupillary miosis (constriction). 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
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

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.

Full Information

First Posted
September 15, 2008
Last Updated
July 14, 2014
Sponsor
Taro Pharmaceuticals USA
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1. Study Identification

Unique Protocol Identification Number
NCT00752973
Brief Title
Safety and Tolerability of a Novel Malathion Formulation in Children Age 6-24 Months With Head Lice
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 Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taro Pharmaceuticals USA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediculosis
Keywords
Head Lice

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment arm
Arm Type
Experimental
Arm Description
MALG treatment
Intervention Type
Drug
Intervention Name(s)
MALG (malathion) Treatment
Other Intervention Name(s)
Novel malathion formulation
Intervention Description
MALG applied for 30 minutes
Primary Outcome Measure Information:
Title
Participants With a Change in Cholinesterase Level at 1 Hour (Day 0).
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
Title
Participants With a Change in Cholinesterase Level at 24 Hrs (1 Day).
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)
Title
Participants With the Clinical Evidence of Cholinesterase Inhibition
Description
Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence of cholinesterase inhibition. Abnormal heart rate. Diarrhea or abdominal cramps. Inappropriate sweating. Pupillary miosis (constriction). 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
Title
Participants With the Clinical Evidence of Cholinesterase Inhibition
Description
Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence cholinesterase inhibition : Abnormal heart rate. Diarrhea or abdominal cramps. Inappropriate sweating. Pupillary miosis (constriction). 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)
Title
Participants With the Clinical Evidence of Cholinesterase Inhibition
Description
Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence of cholinesterase inhibition : Abnormal heart rate. Diarrhea or abdominal cramps. Inappropriate sweating. Pupillary miosis (constriction). 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)
Title
Participants Clinically Cured of Head Lice 14 Days After Last Treatment
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
Secondary Outcome Measure Information:
Title
Evaluation of the Local Safety of Malathion Gel, 0.5% Based Upon Reported Adverse Events and Observed Scalp Reactions.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Investigator Site
City
Bentonville
State/Province
Arkansas
Country
United States
Facility Name
Investigator Site
City
Jonesboro
State/Province
Arkansas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17845167
Citation
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.
Results Reference
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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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