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

December 21, 2023 updated by: Merz Aesthetics GmbH

Prospective, Multicenter, Parallel-group, Evaluator-blind, Randomized Study to Investigate the Effectiveness and Safety of MRZF111 in the Treatment of décolleté Wrinkles

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
117

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Soden, Germany, 65812
        • Merz Investigational Site #0490189
      • Drensteinfurt, Germany, 48317
        • Merz Investigational Site #0490375
      • Hamburg, Germany, 20146
        • Merz Investigational Site #0490095
      • Hamburg, Germany, 22609
        • Merz Investigational Site #0490345
      • Kassel, Germany, 34121
        • Merz Investigational Site #0490309
      • München, Germany, 80539
        • Merz Investigational Site #0490371
      • München, Germany, 80636
        • Merz Investigational Site #0490372
      • Potsdam, Germany, 14467
        • Merz Investigational Site #0490362
      • Wuppertal, Germany, 42287
        • Merz Investigational Site #0490367

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female between ≥18 and ≤65 years old.
  • 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 treatment with fat injections, poly L-lactic acid or permanent dermal fillers (e.g., silicone, polymethyl methacrylate) in the décolleté.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 3 MRZF111 injection cycles
Enrolled subjects will receive 3 injection cycles in total at time points Day 1, Week 8, and Week 16.
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.
Other Names:
  • Radiesse
Experimental: 2 MRZF111 injection cycles
Enrolled subjects will receive 2 injection cycles in total at time points Day 1, and Week 16.
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.
Other Names:
  • Radiesse

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Responder Rate for Décolleté Wrinkles According to the Merz Aesthetics Scale (MAS)-At Rest Scale as Assessed by the Blinded Live Rater
Time Frame: 16 weeks after the last treatment on Week 16 (at Week 32)
The percentage of responders (responder rate) was defined as greater than or equal to (>=) 1-point improvement on MAS décolleté wrinkles from baseline to 16 weeks after last treatment as assessed by the blinded live rater. Responder rate for décolleté wrinkles at rest was assessed using MAS-at rest scale. The MAS-at rest scale included five-point scale: 0 = no wrinkles, 1 = mild wrinkles, 2 = moderate wrinkles, 3 = severe wrinkles, 4 = very severe wrinkles. The higher score indicated the worst outcome.
16 weeks after the last treatment on Week 16 (at Week 32)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Responder Rate for Décolleté Wrinkles According to the MAS-Dynamic Scale as Assessed by the Blinded Live Rater (Last Observation Carried Forward [LOCF])
Time Frame: 16 weeks after the last treatment on Week 16 (at Week 32)
The percentage of responders (responder rate) was defined as >= 1-point improvement on MAS décolleté wrinkles from baseline to 16 weeks after last treatment as assessed by the blinded live rater. Responder rate for décolleté wrinkles at dynamic was assessed using MAS-Dynamic Scale. The MAS-Dynamic Scale included five-point scale: 0 = no wrinkles, 1 = mild wrinkles, 2 = moderate wrinkles, 3 = severe wrinkles, 4 = very severe wrinkles. The higher score indicated the worst outcome.
16 weeks after the last treatment on Week 16 (at Week 32)
Percentage of Participants With Aesthetic Improvement After the Décolleté Wrinkles Treatments Based on Investigator's Treatment Satisfaction Assessment Scale (LOCF)
Time Frame: 16 weeks after the last treatment on Week 16 (at Week 32)
Treatment satisfaction is defined as a rating of +3 (Very satisfied), +2 (Satisfied) or +1 (Somewhat satisfied). The treating investigators were asked to rate their level of satisfaction with the aesthetic appearance of the participant's décolleté after treatment. The investigator responded on a 7-point scale: - 3 = very dissatisfied, - 2 = dissatisfied, - 1 = somewhat dissatisfied, 0 = neither satisfied nor dissatisfied, + 1 = somewhat satisfied, + 2 = satisfied, + 3 = very satisfied. The higher score indicated aesthetic improvement.
16 weeks after the last treatment on Week 16 (at Week 32)
Percentage of Participants With Aesthetic Improvement After the Décolleté Wrinkles Treatments Based on Participant's Treatment Satisfaction Assessment Scale (LOCF)
Time Frame: 16 weeks after the last treatment on Week 16 (at Week 32)
Treatment satisfaction is defined as a rating of +3 (Very satisfied), +2 (Satisfied) or +1 (Somewhat satisfied). The participants were asked to rate their level of satisfaction with the aesthetic appearance of their décolleté after treatment. The participants responded on a 7-point scale: - 3 = very dissatisfied, - 2 = dissatisfied, - 1 = somewhat dissatisfied, 0 = neither satisfied nor dissatisfied, + 1 = somewhat satisfied, + 2 = satisfied, + 3 = very satisfied. The higher score indicated aesthetic improvement.
16 weeks after the last treatment on Week 16 (at Week 32)
Percentage of Participants With Global Aesthetic Improvement Based on the Investigator's Global Aesthetic Improvement Scale on Décolleté Wrinkles (iGAIS-Wrinkles) as Assessed by the Treating Investigator (LOCF)
Time Frame: 16 weeks after the last treatment on Week 16 (at Week 32)
Improvement is defined as a rating of +1 (Improved), +2 (Much improved) or +3 (Very much improved). Treating investigators used iGAIS-Wrinkles to assess aesthetic improvement in participants. The assessment was performed by treating investigator by live rating using standardized pre-treatment photographs for comparison. Treating investigator was asked based on their clinical experience to rate their overall impression of change of participant's décolleté wrinkles due to treatment. The investigator responded on a 7-point scale: - 3 = very much worse, - 2 = much worse, - 1 = worse, 0 = no change, + 1 = improved, + 2 = much improved, + 3 = very much improved. Higher score indicated aesthetic improvement.
16 weeks after the last treatment on Week 16 (at Week 32)
Percentage of Participants With Global Aesthetic Improvement Based on the Subject's Global Aesthetic Improvement Scale on Décolleté Wrinkles (sGAIS-Wrinkles) as Assessed by the Participant (LOCF)
Time Frame: 16 weeks after the last treatment on Week 16 (at Week 32)
Improvement is defined as a rating of +1 (Improved), +2 (Much improved) or +3 (Very much improved). The sGAIS-wrinkles was used to assess aesthetic improvement in the participants. The assessment was performed by the participant by live rating using standardized pre-treatment photographs for comparison. The participant was asked to rate their overall impression of change of their décolleté wrinkles due to treatment. The participant responded on a 7-point scale: - 3 = very much worse, - 2 = much worse, - 1 = worse, 0 = no change, + 1 = improved, + 2 = much improved, + 3 = very much improved.
16 weeks after the last treatment on Week 16 (at Week 32)
Percentage of Participants With at Least One Treatment-related Treatment-emergent Adverse Event (TEAE)
Time Frame: Up to Week 52
Up to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merz Aesthetics GmbH

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merz Pharmaceuticals GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Merz Medical Expert, Merz North America, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 4, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 17, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 23, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M930521001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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