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

Primary Purpose

Pediculosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Malathion gel 0.5%
Permethrin 1% rinse
Sponsored by
Taro Pharmaceuticals USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediculosis focused on measuring Head Lice

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigator Site
  • Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Malathion Gel

Nix Creme Rinse

Arm Description

Malathion gel 0.5% 30 minute application

Nix applied to scalp for 10 minutes

Outcomes

Primary Outcome Measures

Proportion of Index Subjects Free of Any of Lice 14 Days After Their Last Treatment.
Treatment Success was evaluated using the Efficacy Intention to Treat (eITT) (LOCF) Efficacy ITT (eITT) was considered definitive. 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). Index subject: 95 from 254 randomized (the youngest subject in the household who met index case criteria( having nits and at least 3 live lice))
Proportion of Index Subjects Lice-free 2 Weeks After Their Last Treatment
Treatment Success in the Efficacy Intention to Treat (eITT) (No 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).
Proportion of Index Subjects Lice-free 14 Days After Their Last Treatment
Treatment Success in the Per Protocol Population (PPP) The PPP included all subjects who complied strictly with the protocol and had outcome data for all required visits. Superiority analysis in the PPP was considered to be supportive.
Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit.(LOCF)
Treatment Success in the Modified Intention to Treat (Modified ITT) (LOCF) The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit. Subjects with missing efficacy data were included first with LOCF and then with non-LOCF
Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit (Non-LOCF).
Treatment Success in the Modified ITT (non-LOCF) The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit. Subjects with missing efficacy data were included first with LOCF and then with non-LOCF

Secondary Outcome Measures

Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (LOCF))
Treatment Success in the Efficacy ITT (LOCF) The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.
Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (Non LOCF))
Treatment Success in the Efficacy ITT (non LOCF) The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.
Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the PPP
Treatment Success in the PPP The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment. The evaluations in the PPP was considered supportive.
Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF)
Treatment Success in the Modified ITT (LOCF) The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment. The evaluations in the Modified ITT was considered supportive.
Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (Non LOCF)
Treatment Success in the Modified ITT (non LOCF) The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment. The evaluations in the Modified ITT was considered supportive.

Full Information

First Posted
June 23, 2009
Last Updated
July 9, 2014
Sponsor
Taro Pharmaceuticals USA
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1. Study Identification

Unique Protocol Identification Number
NCT00927472
Brief Title
Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice
Official Title
A Multi-Center Phase III Study to Evaluate Ovide Lotion 0.5% Formulation, for the Control of Head Lice in Pediatric Subjects and Adult Subjects With Pediculosis Capitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taro Pharmaceuticals USA

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediculosis
Keywords
Head Lice

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
254 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Malathion Gel
Arm Type
Experimental
Arm Description
Malathion gel 0.5% 30 minute application
Arm Title
Nix Creme Rinse
Arm Type
Active Comparator
Arm Description
Nix applied to scalp for 10 minutes
Intervention Type
Drug
Intervention Name(s)
Malathion gel 0.5%
Intervention Description
Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present.
Intervention Type
Drug
Intervention Name(s)
Permethrin 1% rinse
Other Intervention Name(s)
Nix Creme Rinse
Intervention Description
Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present.
Primary Outcome Measure Information:
Title
Proportion of Index Subjects Free of Any of Lice 14 Days After Their Last Treatment.
Description
Treatment Success was evaluated using the Efficacy Intention to Treat (eITT) (LOCF) Efficacy ITT (eITT) was considered definitive. 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). Index subject: 95 from 254 randomized (the youngest subject in the household who met index case criteria( having nits and at least 3 live lice))
Time Frame
3 weeks
Title
Proportion of Index Subjects Lice-free 2 Weeks After Their Last Treatment
Description
Treatment Success in the Efficacy Intention to Treat (eITT) (No 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).
Time Frame
3 weeks
Title
Proportion of Index Subjects Lice-free 14 Days After Their Last Treatment
Description
Treatment Success in the Per Protocol Population (PPP) The PPP included all subjects who complied strictly with the protocol and had outcome data for all required visits. Superiority analysis in the PPP was considered to be supportive.
Time Frame
3 weeks
Title
Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit.(LOCF)
Description
Treatment Success in the Modified Intention to Treat (Modified ITT) (LOCF) The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit. Subjects with missing efficacy data were included first with LOCF and then with non-LOCF
Time Frame
3 weeks
Title
Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit (Non-LOCF).
Description
Treatment Success in the Modified ITT (non-LOCF) The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit. Subjects with missing efficacy data were included first with LOCF and then with non-LOCF
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (LOCF))
Description
Treatment Success in the Efficacy ITT (LOCF) The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.
Time Frame
3 weeks
Title
Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (Non LOCF))
Description
Treatment Success in the Efficacy ITT (non LOCF) The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.
Time Frame
3 weeks
Title
Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the PPP
Description
Treatment Success in the PPP The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment. The evaluations in the PPP was considered supportive.
Time Frame
3 weeks
Title
Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF)
Description
Treatment Success in the Modified ITT (LOCF) The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment. The evaluations in the Modified ITT was considered supportive.
Time Frame
3 weeks
Title
Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (Non LOCF)
Description
Treatment Success in the Modified ITT (non LOCF) The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment. The evaluations in the Modified ITT was considered supportive.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Investigator Site
City
Bentonville
State/Province
Arkansas
Country
United States
Facility Name
Investigator Site
City
Jonesboro
State/Province
Arkansas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17845167
Citation
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 Creme Rinse (1% permethrin) used as labeled, for the treatment of head lice. Pediatr Dermatol. 2007 Jul-Aug;24(4):405-11. doi: 10.1111/j.1525-1470.2007.00460.x.
Results Reference
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Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice

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