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

Pediculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00752973
• Other study ID #: MALG-0813
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 15, 2008
• Last updated: July 14, 2014
• Start date: September 2008
• Est. completion date: January 2012

Study information

• Verified date: July 2014
• Source: Taro Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 24 Months

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lice Infestations
• Pediculosis

Intervention

Drug:
• MALG (malathion) Treatment
MALG applied for 30 minutes

Locations

Country	Name	City	State
United States	Investigator Site	Bentonville	Arkansas
United States	Investigator Site	Jonesboro	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Taro Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 labe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline to 1 hour	Yes
Primary	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.	Change from baseline to 24 hrs (1 day)	Yes
Primary	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.	at Baseline	Yes
Primary	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.	at 1 hr (Day 0)	Yes
Primary	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.	at 24 hrs (Day 1)	Yes
Primary	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).	Day 7±1 and Day 14 or Day 21	No
Secondary	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.	Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments)	Yes