Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice

Lice Infestations Clinical Trial

Official title:

A Multi-Center Phase III Study to Evaluate MALG, a Novel Malathion 0.05%Formulation, for the Control of Head Lice in Pediatric and Adult Subjects With Pediculosis Capitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00244439
• Other study ID #: MALG-0506
• Status: Completed
• Phase: Phase 3
• First received: October 24, 2005
• Last updated: December 19, 2013
• Start date: December 2005
• 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

Current treatments for head lice include over-the-counter products such as permethrin and prescription products such as OVIDE (malathion 0.5%) lotion. In a previous phase II study, a novel, easy-to-use malathion 0.5% formulation was found to be a safe treatment for head lice. The current study will compare the efficacy and safety of this novel formulation of malathion with OVIDE and with an over-the-counter permethrin product.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: December 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

• Confirmed active head lice infestation

• Patient, parent or guardian must be able to apply the treatment

• Entire household must be screened

• All infested persons must agree to participate

Exclusion Criteria:

• Allergy to pediculicides, hair care products or chrysanthemums

• Scalp conditions other than head lice

• Previous head lice treatment within the past 4 weeks

• Female patients who are pregnant or nursing

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lice Infestations

Intervention

Drug:
• MALG
30 minute application
• Ovide (malathion) lotion 0.05%
8-12 hour application
• Permethrin 1%
10 minute application

Locations

Country	Name	City	State
United States	Investigator Site	Miami	Florida
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	Cure of Head Lice		4 weeks	No
Secondary	Safety of treatments		4 weeks	Yes