Safety and Efficacy of a Novel Malathion Formulation in t... | NCT00244439

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

NCT00244439

Sponsor

Sun Pharmaceutical Industries, Inc.

Status

Completed

Last Update Posted

Dec 23, 2013Estimated

Enrollment

360Actual

Phase

Phase 3

Conditions

Lice Infestations

Interventions

MALG
Ovide (malathion) lotion 0.05%
Permethrin 1%

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2005

Primary Completion Date

Oct 2006Actual

Completion Date

Dec 2006Actual

First Submitted Date

Oct 24, 2005

First Submission Date that Met QC Criteria

Oct 24, 2005

First Posted Date

Oct 26, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2013

Last Update Posted Date

Dec 23, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

360Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	MALG	Drug: MALG
2	Active Comparator	Ovide	Drug: Ovide (malathion) lotion 0.05%
3	Active Comparator	Permethrin 1%	Drug: Permethrin 1%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MALG	Drug	30 minute application	1
Ovide (malathion) lotion 0.05%

Measure	Description	Time Frame
Cure of Head Lice		4 weeks

Measure	Description	Time Frame
Safety of treatments		4 weeks

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Investigator Site		Scottsdale	Arizona		United States
Investigator Site

Condition Browse Module

MeSH Terms

ID	Term
D010373	Lice Infestations

Ancestor Terms

ID	Term
D004478	Ectoparasitic Infestations
D012876	Skin Diseases, Parasitic
D010272	Parasitic Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008294	Malathion

Ancestor Terms

ID	Term
D063086	Organothiophosphates
D010755	Organophosphates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided