Décolleté WrinklesNCT04177212

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

A study testing MRZF111 in people with Décolleté Wrinkles, run by Merz Aesthetics GmbH at 9 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years, women only
Conditions the study is for: Décolleté Wrinkles
What is being tested?: MRZF111
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 117 participants
Where: 9 sitesGermany
Study dates: 4 Dec 2019to 23 Feb 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

Germany9 sites

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

Other trials in Germany

About this study

Official title: 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.

Conditions: Décolleté Wrinkles
Being tested: MRZF111

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MRZF111Device
Also called Radiesse
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.

Study groups in NCT04177212
Study group	Role	What they receive
3 MRZF111 injection cycles	Experimental	Enrolled subjects will receive 3 injection cycles in total at time points Day 1, Week 8, and Week 16. Receives: Device: MRZF111
2 MRZF111 injection cycles	Experimental	Enrolled subjects will receive 2 injection cycles in total at time points Day 1, and Week 16. Receives: Device: MRZF111

What is being measured

The primary outcome is the main question the study is designed to answer.

Responder Rate for Décolleté Wrinkles According to the Merz Aesthetics Scale (MAS)-At Rest Scale as Assessed by the Blinded Live Rater
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.
Measured: 16 weeks after the last treatment on Week 16 (at Week 32)

Secondary outcomes (6)

Responder Rate for Décolleté Wrinkles According to the MAS-Dynamic Scale as Assessed by the Blinded Live Rater (Last Observation Carried Forward [LOCF])
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
Measured: Up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Dec 201923 Feb 2021

First posted26 Nov 2019
Study start4 Dec 2019
Primary completion17 Nov 2020
Study completion23 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Décolleté WrinklesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 117 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04177212
Sponsor's protocol ID: M930521001
Status last verified: Dec 2023
First submitted: 20 Nov 2019
Last updated: 26 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingEarly Phase 1
PIEZO-101 First-in-Human Safety and Proof-of-Concept Study
Skin Aging, Wrinkles in Decolletage
Active, not recruiting
A Study to Determine if RADIESSE® Dilute Treatment in Décolleté of Adult Women Affects Radiographic Imaging Assessments
Décolleté Wrinkles
Active, not recruitingPhase 1
A Phase I Study of KB301, a Replication-Incompetent, Non-Integrating Vector Expressing Human Type III Collagen (COL3) for the Treatment of Superficial Skin Depressions
Skin Roughness, Wrinkle
Active, not recruitingPhase 1/2
A Study Assessing KB304 for the Treatment of Wrinkles in Women
Wrinkles in Decolletage, Pigmentation

All Décolleté Wrinkles trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Multicenter, Parallel-group, Evaluator-blind, Randomized Study to Investigate the Effectiveness and Safety of MRZF111 in the Treatment of décolleté Wrinkles
ClinicalTrials.gov ID: NCT04177212
Acronym / sponsor ID: M930521001
Conditions: Décolleté Wrinkles
Study type: Interventional
Recruitment status: Completed
Enrolment: 117 participants (actual)
Lead sponsor: Merz Aesthetics GmbHIndustry (pharma, biotech, devices)
Collaborators: Merz Pharmaceuticals GmbH
Study start: 4 Dec 2019 (actual)
Primary completion: 17 Nov 2020 (actual)
Study completion: 23 Feb 2021 (actual)
First posted: 26 Nov 2019 (actual)
Results: Posted 26 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
3 MRZF111 injection cycles	Experimental	Device: MRZF111Enrolled subjects will receive 3 injection cycles in total at time points Day 1, Week 8, and Week 16.
2 MRZF111 injection cycles	Experimental	Device: MRZF111Enrolled subjects will receive 2 injection cycles in total at time points Day 1, and Week 16.

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MRZF111Also: RadiesseMRZF111 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.	Device	2 MRZF111 injection cycles, 3 MRZF111 injection cycles

Primary outcome

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.

6 secondary outcomes

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)
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)
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)
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)
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)
Percentage of Participants With at Least One Treatment-related Treatment-emergent Adverse Event (TEAE)
Time frame: Up to Week 52

Results and safety

Results posted to the registry on 26 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A: MRZF111 (3 Injections)	55	43
Group B: MRZF111 (2 Injections)	62	47

Primary outcome: 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). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Group A: MRZF111 (3 Injections) n = 39	Group B: MRZF111 (2 Injections) n = 49	Pooled Treatment Group (Group A: MRZF111 [3 Injections] + Group B: MRZF111 [2 Injections]) n = 117
Value	71.8 (56.2 to 83.5)	83.7 (71.0 to 91.5)	73.5 (62.8 to 82.5)

Pooled Treatment Group (Group A: MRZF111 [3 Injections] + Group B: MRZF111 [2 Injections]): p < 0.0001, One-sided binomial test

Population analysed: The modified full analysis set (FAS) included participants who were treated at least once. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. Modified FAS (observed cases) was used for Groups A and B. Modified FAS (missing data imputed via multiple imputation approach) was used for pooled treatment group.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Week 52. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A: MRZF111 (3 Injections)	4 of 43 (9.3%)	21 of 43 (48.8%)	0 of 43
Group B: MRZF111 (2 Injections)	5 of 74 (6.8%)	25 of 74 (33.8%)	0 of 74

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Décolleté Wrinkles

Not yet recruitingEarly Phase 1
PIEZO-101 First-in-Human Safety and Proof-of-Concept Study
Skin Aging, Wrinkles in Decolletage
Active, not recruiting
A Study to Determine if RADIESSE® Dilute Treatment in Décolleté of Adult Women Affects Radiographic Imaging Assessments
Décolleté Wrinkles
Active, not recruitingPhase 1
A Phase I Study of KB301, a Replication-Incompetent, Non-Integrating Vector Expressing Human Type III Collagen (COL3) for the Treatment of Superficial Skin Depressions
Skin Roughness, Wrinkle
Active, not recruitingPhase 1/2
A Study Assessing KB304 for the Treatment of Wrinkles in Women
Wrinkles in Decolletage, Pigmentation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Merz Medical Expert study director

Merz North America, Inc.

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MRZF111 in people with Décolleté Wrinkles, run by Merz Aesthetics GmbH at 9 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04177212.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.