Hyaluronic Acid Filler IMD1 Basic for Correction of Nasolabial Folds

This study has been completed.

Sponsor:

Information provided by:

Merz Pharmaceuticals GmbH

ClinicalTrials.gov Identifier:

NCT00429520

First received: January 30, 2007

Last updated: February 5, 2008

Last verified: February 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

January 30, 2007

Last Updated Date

February 5, 2008

Start Date ^ICMJE

December 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Severity rating scale assessed by independent rater

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00429520 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Hyaluronic Acid Filler IMD1 Basic for Correction of Nasolabial Folds

Official Title ^ICMJE

Prospective, Multicentre, Not Controlled Clinical Study to Investigate Efficacy and Tolerability of the Hyaluronic Acid Filler IMD1 Basic After Single Bilateral Injection for Correction of Nasolabial Folds (NLF)

Brief Summary

Volunteers receive one injection IMD1 basic of correction of nasolabial folds and are followed-up for up to 36 weeks.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Nasolabial Folds

Intervention ^ICMJE

Drug: Hyaluronic acid filler/IMD1 basic

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

114

Completion Date

December 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

30 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00429520

Other Study ID Numbers ^ICMJE

MRZ 90026-0423/1

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Merz Pharmaceuticals GmbH

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Johannes Reinmüller, MD

Klinik am Sonnenberg, Wiesbaden, Germany

Information Provided By

Merz Pharmaceuticals GmbH

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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