Hyaluronic Acid Filler IMD1 Basic for Correction of Nasol... | NCT00429520

Studies
Hyaluronic Acid Filler IMD1 Basic for Correction of Nasolabial Folds

NCT00429520

Sponsor

Merz Pharmaceuticals GmbH

Status

Completed

Last Update Posted

Feb 7, 2008Estimated

Enrollment

114

Phase

Phase 4

Conditions

Nasolabial Folds

Interventions

Hyaluronic acid filler/IMD1 basic

Countries

Germany

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

Feb 2008

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

Not provided

Completion Date

Dec 2006

First Submitted Date

Jan 30, 2007

First Submission Date that Met QC Criteria

Jan 30, 2007

First Posted Date

Jan 31, 2007Estimated

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

Feb 5, 2008

Last Update Posted Date

Feb 7, 2008Estimated

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

114

Name	Type	Description	Arm Group Labels	Other Names
Hyaluronic acid filler/IMD1 basic	Drug

Measure	Description	Time Frame
Severity rating scale assessed by independent rater

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

main inclusion criteria: severity rating scale grade 3 or 4

Exclusion Criteria:

main exclusion criterion: other nasolabial fold corrections within 6 months prior to study entry

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Johannes Reinmüller, MD	Klinik am Sonnenberg, Wiesbaden, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Merz Pharmaceuticals		Frankfurt		60318	Germany