Comparison of the Efficacy and Safety of Ivermectin to Pe... | NCT00262418

Studies
Comparison of the Efficacy and Safety of Ivermectin to Permethrin

NCT00262418

Sponsor

University Ghent

Status

Completed

Last Update Posted

Dec 28, 2007Estimated

Enrollment

160Actual

Phase

Phase 2

Conditions

Scabies

Interventions

Administration of ivermectin or permethrin

Countries

Belgium

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

Dec 2007

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

Jul 2004

Primary Completion Date

Not provided

Completion Date

May 2005Actual

First Submitted Date

Dec 4, 2005

First Submission Date that Met QC Criteria

Dec 4, 2005

First Posted Date

Dec 6, 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, 2007

Last Update Posted Date

Dec 28, 2007Estimated

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

Comparison of the efficacy and safety of a single administration of ivermectin to a single administration of permethrin for the treatment of scabies

Detailed Description

Administration of ivermectin or permethrin on day0 Clinical examination and pictures on day0, day14 and day28 Blood sample on day0 VAS for pruritus, DLQI and SF-36 on day0, day14 and day28

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

160Actual

Name	Type	Description	Arm Group Labels	Other Names
Administration of ivermectin or permethrin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical healing of the skin injuries		on day28

Secondary Outcomes

Measure	Description	Time Frame
Decrease of itching		on day28
Amelioration of the life quality		on day28
Number and gravity of adverse events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At least one of the following inclusion criteria:

Scabies tunnels
Positive microscopic examination (acarids, faeces or ova)

At least two of the three following inclusion criteria:

Non-specific injuries with a typical distribution pattern
Serious itching which increases during the night
Family or contacts with similar complaints

Exclusion Criteria:

Treatment for scabies < 4 weeks ago
Treatment with corticoids < 1 week ago
Pregnancy
Breast-feeding
HIV
Serious immunodepressive patients
Sensitivity or allergy to one of the components of the study medication
Damage of the central nerve system

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 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

Name	Affiliation	Role
Jean-Marie Naeyaert, MD, PhD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Ghent		Ghent		9000	Belgium

Label	URL
Website of the University Hospital Ghent	View source

Condition Browse Module

MeSH Terms

ID	Term
D012532	Scabies

Ancestor Terms

ID	Term
D008924	Mite Infestations
D004478	Ectoparasitic Infestations
D012876	Skin Diseases, Parasitic
D010272	Parasitic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D026023	Permethrin

Ancestor Terms

ID	Term
D010647	Phenyl Ethers
D004987	Ethers
D009930	Organic Chemicals
D010636	Phenols
D001555

Browse Leaves

Not provided

Browse Branches

Not provided