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Hyaluronic Acid Filler IMD1 Basic for Correction of Nasolabial Folds

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00429520
First Posted: January 31, 2007
Last Update Posted: February 7, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Merz Pharmaceuticals GmbH
  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
Intervention Model: Single Group Assignment
Masking: None (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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00429520     History of Changes
Other Study ID Numbers: MRZ 90026-0423/1
First Submitted: January 30, 2007
First Posted: January 31, 2007
Last Update Posted: February 7, 2008
Last Verified: February 2008

Additional relevant MeSH terms:
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents