Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice

Pediculosis Clinical Trial

Official title:

A Multi-Center Phase III Study to Evaluate Malathion Gel 0.5% Formulation, for the Control of Head Lice in Pediatric Subjects and Adult Subjects With Pediculosis Capitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00963508
• Other study ID #: MALG-0816
• Status: Completed
• Phase: Phase 3
• First received: August 14, 2009
• Last updated: May 14, 2014
• Start date: August 2009
• Est. completion date: March 2010

Study information

• Verified date: May 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 this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an established head lice treatment. The new formulation has been evaluated in 2 previous studies of patients 2 years of age and older.

Description:

This is a Phase III, multi-center, investigator-blinded, two-arm, randomized, parallel group study, evaluating the safety and efficacy of a Malathion Gel, 0.5% formulation, manufactured by Taro. The objective is to show superiority of the novel product to an active control, Nix® Crème Rinse, manufactured by Insight Pharmaceuticals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

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

Related Conditions & MeSH terms

• Lice Infestations
• Pediculosis

Intervention

Drug:
• Malathion gel 0.5%
Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present.
• Permethrin 1% rinse (Nix Crème)
Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present.

Locations

Country	Name	City	State
United States	Investigator Site	Hot Springs	Arkansas
United States	Investigator Site	Kissimmee	Florida
United States	Investigator Site	Miami	Florida
United States	Investigator Site	Ormond Beach	Florida
United States	Investigator Site	Picayune	Mississippi
United States	Investigator Site	Sacramento	California
United States	Investigator Site	San Antonio	Texas

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	Proportion of Index Subjects Free of Any Lice 14 Days After Their Last Treatment in the Modified ITT (LOCF)	The primary efficacy variable was the proportion of index subjects who were considered a Treatment Success 14 days after their last treatment (Day 14 visit if only treated on Day 1, Day 21 visit if treated on Day 1 and Day 7); Treatment Success in the Efficacy ITT (LOCF); index subjects: 150 from 403 randomized (the youngest subject in the household that met the index case criteria (having nits and at least 3 live lice))	3 weeks	No
Secondary	Proportion of Subjects Who Were Considered a Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF).	The secondary efficacy variable was the proportion of subjects who were considered a Treatment Success 14 days after their first treatment.; Treatment Success in the Efficacy ITT (LOCF)	3 weeks	Yes