Safety and Tolerability of a Novel Malathion Formulation... | NCT00291057

Studies
Safety and Tolerability of a Novel Malathion Formulation in Infants and Toddlers With Head Lice

NCT00291057

Sponsor

Sun Pharmaceutical Industries, Inc.

Status

Terminated

Last Update Posted

Dec 23, 2013Estimated

Enrollment

30Estimated

Phase

Phase 2

Conditions

Lice Infestations

Interventions

MALG

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

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of enrollment

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Oct 2006Actual

Completion Date

Dec 2006Actual

First Submitted Date

Feb 10, 2006

First Submission Date that Met QC Criteria

Feb 10, 2006

First Posted Date

Feb 13, 2006Estimated

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

In a previous phase II study, the safety and efficacy of a novel formulation of malathion 0.5% was evaluated in patients 2 years of age and older. Based on the results of that study, this formulation is currently in a phase III study for that population.

The current study will use blood markers and clinical evaluations to determine the safety and tolerability of this formulation when used in children 6-24 months of age.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	MALG	Drug: MALG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MALG	Drug	30 minute application	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in cholinesterase level		1 day

Secondary Outcomes

Measure	Description	Time Frame
Clinical evidence of cholinesterase inhibition		1 day
Local tolerability		1 day
Cure of head lice 14 days after last treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed active head lice infestation
Parent or guardian must be able to apply treatment

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

24 Months

Standard Ages

Child

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