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Completed

NCT Number: NCT00752973

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

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.

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Key information

Conditions

Pediculosis Ectoparasitic Infestations Infections Lice Infestations Parasitic Diseases Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic Skin and Connective Tissue Diseases

Age range

6 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Investigator Site, Bentonville, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MALG (malathion) Treatment

Drug

MALG applied for 30 minutes

Other names: Novel malathion formulation

Primary outcomes

  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.

    • 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.

  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 :

    • 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.

  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 :

    • 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.

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Sep 16, 2008
Registry last updated
Aug 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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