Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Hyaluronic Acid Filler IMD1 Basic for Correction of Nasolabial Folds

This study has been completed.
Information provided by:
Merz Pharmaceuticals GmbH Identifier:
First received: January 30, 2007
Last updated: February 5, 2008
Last verified: February 2008

January 30, 2007
February 5, 2008
December 2005
Not Provided
Severity rating scale assessed by independent rater
Same as current
Complete list of historical versions of study NCT00429520 on Archive Site
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Hyaluronic Acid Filler IMD1 Basic for Correction of Nasolabial Folds
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)

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

Not Provided
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Nasolabial Folds
Drug: Hyaluronic acid filler/IMD1 basic
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2006
Not Provided

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
30 Years to 60 Years
Contact information is only displayed when the study is recruiting subjects
MRZ 90026-0423/1
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Not Provided
Merz Pharmaceuticals GmbH
Not Provided
Principal Investigator: Johannes Reinmüller, MD Klinik am Sonnenberg, Wiesbaden, Germany
Merz Pharmaceuticals GmbH
February 2008

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