Safety and Tolerability of a Novel Malathion Formulation in Infants and Toddlers With Head Lice

Lice Infestations 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: Terminated

Administrative data

• NCT number: NCT00291057
• Other study ID #: MALG-0508
• Status: Terminated
• Phase: Phase 2
• First received: February 10, 2006
• Last updated: December 19, 2013
• Start date: February 2006
• Est. completion date: December 2006

Study information

• Verified date: November 2013
• 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: Terminated
• Enrollment: 30
• Est. completion date: December 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 24 Months

Eligibility

Inclusion Criteria:

• Confirmed active head lice infestation

• Parent or guardian must be able to apply treatment

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 Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lice Infestations

Intervention

Drug:
• MALG
30 minute application

Locations

Country	Name	City	State
United States	Investigator Site	Miamiville	Ohio
United States	Investigator Site	New York	New York
United States	Investigator Site	Scottsdale	Arizona
United States	Investigator Site	St. Petersburg	Florida
United States	Investigator Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Taro Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cholinesterase level		1 day	Yes
Secondary	Clinical evidence of cholinesterase inhibition		1 day	Yes
Secondary	Local tolerability		1 day	Yes
Secondary	Cure of head lice 14 days after last treatment		2 weeks	No