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)
Volunteers receive one injection IMD1 basic of correction of nasolabial folds and are followed-up for up to 36 weeks.
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Merz Pharmaceuticals | Frankfurt |
Lead Sponsor | Collaborator |
---|---|
Merz Pharmaceuticals GmbH |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Severity rating scale assessed by independent rater |
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