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Investigation of the Effectiveness and Safety of MRZF111 in the Treatment of Décolleté Wrinkles

NCT04177212 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2023-12-26

Study results available
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Summary

To evaluate the effectiveness and safety of MRZF111 treatment for improvement of décolleté wrinkles as assessed on the Merz Aesthetics Scales (MAS) Décolleté Wrinkles-At Rest.

Conditions

  • Décolleté Wrinkles

Interventions

DEVICE

MRZF111

MRZF111 kit consisting of one syringe of RADIESSE® Volume injectable implant, injection needles and additional components. Physiological saline solution (0.9% NaCl) is used to dilute Radiesse Volume by 1:2. Radiesse consists of calcium hydroxylapatite particles suspended in an aqueous-based gel carrier.

Sponsors & Collaborators

  • Merz Pharmaceuticals GmbH

    collaborator INDUSTRY

  • Merz Aesthetics GmbH

    lead INDUSTRY

Principal Investigators

  • Merz Medical Expert · Merz North America, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-04
Primary Completion
2020-11-17
Completion
2021-02-23
FDA Device
Yes

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04177212 on ClinicalTrials.gov