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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
  Purpose

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


Condition Intervention Phase
Nasolabial Folds
 Drug: Hyaluronic acid filler/IMD1 basic
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:
  • Severity rating scale assessed by independent rater

Estimated Enrollment: 114
Study Start Date: December 2005
Estimated Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429520

Locations
Germany
Merz Pharmaceuticals
Frankfurt, Germany, 60318
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Investigators
Principal Investigator: Johannes Reinmüller, MD Klinik am Sonnenberg, Wiesbaden, Germany
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00429520     History of Changes
Other Study ID Numbers: MRZ 90026-0423/1
Study First Received: January 30, 2007
Last Updated: February 5, 2008
Health Authority: 'Federal Institute for Drugs and Medicinal Devices: Germany'

Additional relevant MeSH terms:
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013