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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

Tracking Information
First Submitted Date  ICMJE September 15, 2008
First Posted Date  ICMJE September 16, 2008
Results First Submitted Date  ICMJE February 19, 2014
Results First Posted Date  ICMJE April 3, 2014
Last Update Posted Date August 7, 2014
Study Start Date  ICMJE September 2008
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2014)
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2008)
Change in Cholinesterase Level [ Time Frame: 1 day ]
Change History Complete list of historical versions of study NCT00752973 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2014)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2008)
  • Clinical Evidence of Cholinesterase Inhibition [ Time Frame: 1 day ]
  • Local Tolerability [ Time Frame: 2-3 weeks ]
  • Cure of Head Lice 14 Days After Last Treatment [ Time Frame: 2-3 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability of a Novel Malathion Formulation in Children Age 6-24 Months With Head Lice
Official Title  ICMJE Phase II, Multi-Center, Open-Label, Safety and Tolerance Study of a Novel Malathion Formulation in Infants and Toddlers With Pediculosis Capitis
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pediculosis
Intervention  ICMJE Drug: MALG (malathion) Treatment
MALG applied for 30 minutes
Other Name: Novel malathion formulation
Study Arms  ICMJE Experimental: Treatment arm
MALG treatment
Intervention: Drug: MALG (malathion) Treatment
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 Crème Rinse (1% permethrin) used as labeled, for the treatment of head lice. Pediatr Dermatol. 2007 Jul-Aug;24(4):405-11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2014)
12
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2008)
30
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 24 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00752973
Other Study ID Numbers  ICMJE MALG-0813
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Taro Pharmaceuticals USA
Study Sponsor  ICMJE Taro Pharmaceuticals USA
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Taro Pharmaceuticals USA
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP