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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
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