Hyaluronic Acid Filler IMD1 Basic for Correction of Nasolabial Folds

Overview

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

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

Interventions

  • Drug: Hyaluronic acid filler/IMD1 basic

Clinical Trial Outcome Measures

Primary Measures

  • Severity rating scale assessed by independent rater

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Merz Pharmaceuticals GmbH
  • Overall Official(s)
    • Johannes Reinm├╝ller, MD, Principal Investigator, Klinik am Sonnenberg, Wiesbaden, Germany

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