Décolleté WrinklesNCT05163353

Evaluation of the Effectiveness and Safety of Diluted RADIESSE® in the Treatment of Décolleté Wrinkles

A study testing Treatment with diluted Radiesse in people with Décolleté Wrinkles, run by Merz North America, Inc. at 9 sites in United States.

Completed

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

Official record

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Trial summary

Trial to confirm the effectiveness and demonstrate the safety of treatment with diluted Radiesse for correction of Décolleté Wrinkles. Read more about this study

Who is it for?: Ages 30 to 65 years, women only
Conditions the study is for: Décolleté Wrinkles
What is being tested?: Treatment with diluted Radiesse
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 152 participants
Where: 9 sitesUnited States
Study dates: 10 Dec 2021to 11 Jun 2025
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 30 to 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Female between ≥ 30 and ≤ 65 years old at the time of the screening.
Subjects seeking improvement of décolleté wrinkles.

Who cannot join

Any previous surgery, including plastic surgery or permanent surgical implant in the treatment area.
Previous treatment with collagen fillers, calcium hydroxylapatite, and/or long-lasting hyaluronic acid (HA) fillers in the décolleté, or with other HA fillers in the décolleté.
Previous treatment with botulinum toxin, ablative or fractional laser, microdermabrasion, microneedling, chemical peels, and/or non-invasive skin tightening in the décolleté.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

The Graivier Center, Merz Investigational Site #0010464
Alpharetta, Georgia, 30005
Clinical Testing of Beverly Hills, Merz Investigational Site #0010395
Beverly Hills, California, 90210
Skin Associates of South Florida, Merz Investigational Site #0010101
Coral Gables, Florida, 33146
Nashville Center for Laser and Facial Surgery, Merz Investigational Site #0010353
Nashville, Tennessee, 37203
Facial Plastic Surgery, Merz Investigational Site #0010463
Redondo Beach, California, 90277
Cosmetic Laser Dermatology, Merz Investigational Site #0010321
San Diego, California, 92121
Private Practice, Merz Investigational Site #0010299
Santa Monica, California, 90404
Face Beautiful Inc, Merz Investigational Site #0010358
Vista, California, 92083
Research Institute of the Southeast, LLC, Merz Investigational Site #0010420
West Palm Beach, Florida, 33401

Other trials in United States

About this study

Official title: Prospective, Multicenter, Controlled, Evaluator-blind, Randomized Study to Investigate the Effectiveness and Safety of Diluted RADIESSE® for Treatment of Décolleté Wrinkles

Trial to confirm the effectiveness and demonstrate the safety of treatment with diluted Radiesse for correction of Décolleté Wrinkles.

Conditions: Décolleté Wrinkles
Being tested: Treatment with diluted Radiesse

What participants receive

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

Treatment with diluted RadiesseDevice
Injection of Décolleté Wrinkles with diluted Radiesse

Study groups in NCT05163353
Study group	Role	What they receive
Treatment with diluted Radiesse	Experimental	Injection of Décolleté Wrinkles with diluted Radiesse Receives: Device: Treatment with diluted Radiesse
Delayed treatment with diluted Radiesse	Other	Delayed injection of Décolleté Wrinkles with diluted Radiesse Receives: Device: Treatment with diluted Radiesse

What is being measured

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

Percentage of Responders on Merz Aesthetic Scale (MAS) Décolleté Wrinkles - at Rest at Week 24
The percentage of responders (responder rate) was defined as the percentage of subjects achieving greater than or equal to (>=) 1-point improvement on MAS décolleté wrinkles-at Rest from baseline to Week 24 as assessed by the blinded evaluator. Responder rate was assessed using MAS-at rest scale, where 0 = no wrinkles, 1 = mild wrinkles, 2 = moderate wrinkles, 3 = severe wrinkles, 4 = very severe wrinkles. Higher score indicated the worse outcome. This analysis was done using multiple imputation method to impute missing values.
Measured: Week 24

Secondary outcomes (4)

Percentage of Responders on MAS Décolleté Wrinkles - Dynamic at Week 24
The percentage of responders (responder rate) was defined as the percentage of subjects achieving >= 1-point improvement on MAS décolleté wrinkles-Dynamic from baseline to Week 24 as assessed by the blinded evaluator. Responder rate was assessed using MAS-Dynamic scale, where 0 = no wrinkles, 1 = mild wrinkles, 2 = moderate wrinkles, 3 = severe wrinkles, 4 = very severe wrinkles. Higher score indicated the worse outcome. This analysis was done using multiple imputation method to impute missing values.
Measured: Week 24
Percentage of Subjects With Any Improvement on Investigator Global Aesthetic Improvement Scale (iGAIS) at Week 24
Improvement is defined as a rating of +1 (Improved), +2 (Much improved) or +3 (Very much improved). Treating investigators used iGAIS, where - 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: Week 24
Percentage of Subjects With Any Improvement on Subject Global Aesthetic Improvement Scale (sGAIS) at Week 24
Improvement is defined as a rating of +1 (Improved), +2 (Much improved) or +3 (Very much improved). Subjects used the sGAIS, where - 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: Week 24
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) Related to Radiesse
TEAEs are defined as AEs with onset on or after date of first administration of study treatment. Treatment related TEAEs are defined as any TEAEs related to diluted Radiesse treatment (that is, related to either injection procedure and/or device).
Measured: From initial treatment (Day 1 for Treatment group and Week 24 for Control/Delayed treatment group) up to end of the study (up to Week 84)

Timeline

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

10 Dec 202111 Jun 2025

First posted20 Dec 2021
Study start10 Dec 2021
Primary completion29 Sep 2022
Study completion11 Jun 2025

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: 152 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05163353
Sponsor's protocol ID: M930521003
Status last verified: Sep 2025
First submitted: 6 Dec 2021
Last updated: 20 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
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 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Multicenter, Controlled, Evaluator-blind, Randomized Study to Investigate the Effectiveness and Safety of Diluted RADIESSE® for Treatment of Décolleté Wrinkles
ClinicalTrials.gov ID: NCT05163353
Acronym / sponsor ID: M930521003
Conditions: Décolleté Wrinkles
Study type: Interventional
Recruitment status: Completed
Enrolment: 152 participants (actual)
Lead sponsor: Merz North America, Inc.Industry (pharma, biotech, devices)
Study start: 10 Dec 2021 (actual)
Primary completion: 29 Sep 2022 (actual)
Study completion: 11 Jun 2025 (actual)
First posted: 20 Dec 2021 (actual)
Results: Posted 20 Oct 2025

Clinical summary

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

Trial to confirm the effectiveness and demonstrate the safety of treatment with diluted Radiesse for correction of Décolleté Wrinkles.

Study design

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

Arm	Type	Receives
Treatment with diluted Radiesse	Experimental	Device: Treatment with diluted RadiesseInjection of Décolleté Wrinkles with diluted Radiesse
Delayed treatment with diluted Radiesse	Other	Device: Treatment with diluted RadiesseDelayed injection of Décolleté Wrinkles with diluted Radiesse

Who may qualify

Ages: 30 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Female between ≥ 30 and ≤ 65 years old at the time of the screening.
Subjects seeking improvement of décolleté wrinkles.

Key exclusion criteria (3 listed)

Any previous surgery, including plastic surgery or permanent surgical implant in the treatment area.
Previous treatment with collagen fillers, calcium hydroxylapatite, and/or long-lasting hyaluronic acid (HA) fillers in the décolleté, or with other HA fillers in the décolleté.
Previous treatment with botulinum toxin, ablative or fractional laser, microdermabrasion, microneedling, chemical peels, and/or non-invasive skin tightening in the décolleté.

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
Treatment with diluted RadiesseInjection of Décolleté Wrinkles with diluted Radiesse	Device	Delayed treatment with diluted Radiesse, Treatment with diluted Radiesse

Primary outcome

Percentage of Responders on Merz Aesthetic Scale (MAS) Décolleté Wrinkles - at Rest at Week 24
Time frame: Week 24
The percentage of responders (responder rate) was defined as the percentage of subjects achieving greater than or equal to (>=) 1-point improvement on MAS décolleté wrinkles-at Rest from baseline to Week 24 as assessed by the blinded evaluator. Responder rate was assessed using MAS-at rest scale, where 0 = no wrinkles, 1 = mild wrinkles, 2 = moderate wrinkles, 3 = severe wrinkles, 4 = very severe wrinkles. Higher score indicated the worse outcome. This analysis was done using multiple imputation method to impute missing values.

4 secondary outcomes

Percentage of Responders on MAS Décolleté Wrinkles - Dynamic at Week 24
Time frame: Week 24
Percentage of Subjects With Any Improvement on Investigator Global Aesthetic Improvement Scale (iGAIS) at Week 24
Time frame: Week 24
Percentage of Subjects With Any Improvement on Subject Global Aesthetic Improvement Scale (sGAIS) at Week 24
Time frame: Week 24
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) Related to Radiesse
Time frame: From initial treatment (Day 1 for Treatment group and Week 24 for Control/Delayed treatment group) up to end of the study (up to Week 84)

Results and safety

Results posted to the registry on 20 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment With Radiesse	116	81
Untreated Control/Delayed Treatment With Radiesse	36	27

Primary outcome: Percentage of Responders on Merz Aesthetic Scale (MAS) Décolleté Wrinkles - at Rest at Week 24

Time frame: Week 24. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	Treatment With Radiesse n = 116	Untreated Control/Delayed Treatment With Radiesse n = 36
Value	71.2 (61.4 to 79.4)	6.3 (1.5 to 22.9)

Treatment With Radiesse vs Untreated Control/Delayed Treatment With Radiesse: Difference in response rates: 65.0 (95% CI 45.6 to 74.4)

Population analysed: ITT Analysis Set.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From initial treatment (Day 1 for Treatment group and Week 24 for Control/Delayed treatment group) up to end of the study (up to Week 84). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment With Radiesse	2 of 116 (1.7%)	17 of 116 (14.7%)	0 of 116
Untreated Control/Delayed Treatment With Radiesse	0 of 36 (0%)	2 of 36 (5.6%)	0 of 36

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing Treatment with diluted Radiesse in people with Décolleté Wrinkles, run by Merz North America, Inc. at 9 sites in United States.

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 3 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 20 Oct 2025. 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 United States. 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 20 Oct 2025). 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?

Percentage of Responders on Merz Aesthetic Scale (MAS) Décolleté Wrinkles - at Rest at Week 24 (time frame: Week 24). 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 NCT05163353.

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 20 Oct 2025.