Investigation of the Effectiveness and Safety of MRZF111 in the Treatment of Décolleté Wrinkles
NCT ID: NCT04177212
Last Updated: 2023-12-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
117 participants
INTERVENTIONAL
2019-12-04
2021-02-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
3 MRZF111 injection cycles
Enrolled subjects will receive 3 injection cycles in total at time points Day 1, Week 8, and Week 16.
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.
2 MRZF111 injection cycles
Enrolled subjects will receive 2 injection cycles in total at time points Day 1, and Week 16.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Décolleté wrinkles with a rating of moderate to severe (grade 2 to 3) on the MAS Décolleté Wrinkles-At Rest as determined by the blinded live rater and confirmed by the treating investigator afterwards.
Exclusion Criteria
* Any previous surgery, including plastic surgery, or surgical permanent implant in the décolleté or in the breasts that could interfere with effectiveness and safety.
* Any previous thread lifting in the décolleté.
* Previous treatment with collagen fillers, calcium hydroxylapatite (CaHa), and/or long-lasting hyaluronic acid (HA) fillers (e.g., Belotero® Intense/Volume, Juvéderm® Volift/Volbella) in the décolleté within the past 24 months before baseline.
* Previous treatment with other HA fillers in the décolleté within the past 12 months before baseline.
* Previous treatment with botulinum toxin, ablative or fractional laser, microdermabrasion, microneedling, chemical peels and/or non-invasive skin tightening (e.g., ultrasound, radiofrequency, intense pulsed light treatment) in the décolleté within the past 6 months before baseline.
18 Years
65 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merz Pharmaceuticals GmbH
INDUSTRY
Merz Aesthetics GmbH
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Merz Medical Expert
Role: STUDY_DIRECTOR
Merz North America, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Merz Investigational Site #0490189
Bad Soden, , Germany
Merz Investigational Site #0490375
Drensteinfurt, , Germany
Merz Investigational Site #0490095
Hamburg, , Germany
Merz Investigational Site #0490345
Hamburg, , Germany
Merz Investigational Site #0490309
Kassel, , Germany
Merz Investigational Site #0490371
München, , Germany
Merz Investigational Site #0490372
München, , Germany
Merz Investigational Site #0490362
Potsdam, , Germany
Merz Investigational Site #0490367
Wuppertal, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M930521001
Identifier Type: -
Identifier Source: org_study_id