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NCT00429520 Clinical Trial

Hyaluronic Acid Filler IMD1 Basic for Correction of Nasolabial Folds

Nasolabial Folds Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00429520
Other study ID # MRZ 90026-0423/1
Secondary ID
Status Completed
Phase Phase 4
First received January 30, 2007
Last updated February 5, 2008
Start date December 2005
Est. completion date December 2006

Study information
Verified date February 2008
Source Merz Pharmaceuticals GmbH
Contact n/a
Is FDA regulated No
Health authority 'Federal Institute for Drugs and Medicinal Devices: Germany'
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 114
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 30 Years to 60 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Hyaluronic acid filler/IMD1 basic

Locations
Country Name City State
Germany Merz Pharmaceuticals Frankfurt

Sponsors (1)
Lead Sponsor Collaborator
Merz Pharmaceuticals GmbH

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Severity rating scale assessed by independent rater
See also
  Status Clinical Trial Phase
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Completed NCT01115634 - Autologous Fibroblast Transplantation in Facial Deformities Phase 2
Completed NCT00778531 - Protocol for the Post-approval Study of ArteFill® for Correction of Nasolabial Folds Phase 4
Completed NCT03932045 - A Study to Evaluate the Safety and Efficacy of SYB Filler(SF-01) in the Correction of Nasolabial Folds N/A
Completed NCT02647853 - Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel in Healthy Volunteers Phase 1
Completed NCT01069354 - Evaluation of Pain With Radiesse® With Lidocaine for Nasolabial Folds N/A
Completed NCT00850889 - Juvederm Ultra With Lidocaine Compared With Restylane for the Correction of Nasolabial Folds Phase 4
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Recruiting NCT06093321 - A Study Comparing SYB PDO Thread and MINT Lift® for Temporary Nasolabial Fold Improvement N/A
Not yet recruiting NCT06295172 - A Study Comparing Lafullen15 and Lafullen for Temporary Nasolabial Fold Improvement N/A
Completed NCT01060943 - An Efficacy and Safety Study of TheraFill® Versus KOKEN for 3 Months on Nasolabial Folds Phase 3
Completed NCT05612958 - Efficacy and Safety of a 'Graft/Prosthesis, Biomaterial (DKM410)' in the Treatment of Both Nasolabial Folds N/A
Completed NCT02672644 - Non-comparative Evaluation of Facial Expressions Following Lower Face Correction Using Emervel Classic and Emervel Deep Phase 4
Completed NCT01012388 - Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of Color Phase 4
Completed NCT01635855 - Belotero Post Approval Study Phase 4
Completed NCT02179736 - A Post Market Evaluation After Treatment of Nasolabial Folds N/A
Terminated NCT00716443 - Evaluate Efficacy, Safety & Subject Satisfaction of Pain Management With Pliaglis® Cream for Dermal Filler Injections Phase 4
Recruiting NCT02607670 - Phase 2 Study of TAT4 Gel for Reduction of Nasolabial Folds Phase 2
Completed NCT00823069 - Safety Study That Compares Perlane to Perlane With Lidocaine (Perlane-L) While Correcting Wrinkles in the Area Around Your Nose N/A