NCT00927472

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

August 4, 2014

Completed
Last Updated

August 4, 2014

Status Verified

July 1, 2014

Enrollment Period

9 months

First QC Date

June 23, 2009

Results QC Date

January 17, 2014

Last Update Submit

July 9, 2014

Conditions

Pediculosis

Keywords

Head Lice

Outcome Measures

Primary Outcomes (5)

  • 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))

    3 weeks

  • 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).

    3 weeks

  • 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.

    3 weeks

  • 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

    3 weeks

  • 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

    3 weeks

Secondary Outcomes (5)

  • Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (LOCF))

    3 weeks

  • Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (Non LOCF))

    3 weeks

  • Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the PPP

    3 weeks

  • Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF)

    3 weeks

  • Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (Non LOCF)

    3 weeks

Study Arms (2)

Malathion Gel

EXPERIMENTAL

Malathion gel 0.5% 30 minute application

Drug: Malathion gel 0.5%

Nix Creme Rinse

ACTIVE COMPARATOR

Nix applied to scalp for 10 minutes

Drug: Permethrin 1% rinse

Interventions

Malathion gel 0.5%DRUG

Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present.

Malathion Gel
Permethrin 1% rinseDRUG

Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present.

Also known as: Nix Creme Rinse
Nix Creme Rinse

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed active head lice infestation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Investigator Site

Bentonville, Arkansas, United States

Location

Investigator Site

Jonesboro, Arkansas, United States

Location

Related 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 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.

    PMID: 17845167BACKGROUND

MeSH Terms

Conditions

Lice Infestations

Interventions

Permethrin

Condition Hierarchy (Ancestors)

Ectoparasitic InfestationsSkin Diseases, ParasiticParasitic DiseasesInfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenyl EthersEthersOrganic ChemicalsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPyrethrinsCyclopentane MonoterpenesMonoterpenesTerpenes

Results Point of Contact

Title
Director, Clinical Research
Organization
Taro Pharmaceuticals U.S.A.,
Natalie.Yantovskiy@Taro.com
914-345-9001

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2009

First Posted

June 25, 2009

Study Start

August 1, 2009

Primary Completion

May 1, 2010

Study Completion

June 1, 2010

Last Updated

August 4, 2014

Results First Posted

August 4, 2014

Record last verified: 2014-07

Locations

US(2)