Radiesse for Chest Area Imaging

Overseen By Public Disclosure Manager

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Merz North America, Inc.

Disqualifiers: Breast cancer, Malignant disease, Surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 13 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Radiesse, a treatment for reducing chest wrinkles, affects breast tissue appearance in medical imaging tests such as mammograms and ultrasounds. Participants will receive three Radiesse injections over several weeks. Individuals with moderate to severe chest wrinkles who are willing to undergo multiple imaging tests may be suitable for this trial. Participants should not have any serious breast conditions or a history of breast cancer. As an unphased trial, this study provides a unique opportunity to contribute to understanding the cosmetic and medical imaging effects of Radiesse.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Radiesse is safe for use in the décolleté area?

Research has shown that Radiesse, a type of skin filler, is generally safe when used correctly. Used for nearly 20 years, it is approved in some countries, such as Canada, for reducing wrinkles in the chest area, indicating its likely safety.

However, some reports of side effects exist. Between 2018 and 2025, the manufacturer received 44 reports of possible side effects, including serious issues in the chest area. Despite this, experts like dermatologists and plastic surgeons reviewed Radiesse in 2019 and confirmed its general safety when used properly.

Overall, while some risks exist, most people tolerate Radiesse well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for chest area rejuvenation, which often involves topical creams or laser treatments, Radiesse is unique because it is an injectable filler that provides immediate volume and stimulates natural collagen production over time. This dual action not only smoothens the skin but also promotes long-term improvement in skin texture and firmness. Researchers are excited about Radiesse because it offers both instant results and sustained benefits, potentially reducing the need for frequent maintenance treatments.

What evidence suggests that Radiesse is effective for chest area imaging?

Research has shown that Radiesse effectively thickens and firms skin while reducing wrinkles. It improves skin in 95% of people aged 30–40, 80% of those aged 40–60, and 70% of those over 60. Radiesse acts as a regenerative biostimulator, helping to rebuild skin components and resulting in healthier-looking skin. In this trial, participants will receive three injections of Radiesse in the décolleté area to study its effects on breast tissue imaging. Although this study focuses on Radiesse's potential impact on breast tissue imaging, strong evidence supports its benefits for skin improvement. ^{2 6 7 8 9}

Who Is on the Research Team?

Merz Medical Expert

Principal Investigator

Merz North America, Inc.

Are You a Good Fit for This Trial?

This trial is for adult women who want to reduce moderate to severe wrinkles in the décolleté area (upper chest) and are willing to undergo multiple mammograms and ultrasound procedures.

Inclusion Criteria

I want to improve moderate to severe chest wrinkles.

I am willing to have up to 3 mammograms and 4 ultrasound scans.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive three injections of Radiesse in the Décolleté at Weeks 1, 7, and 13

13 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of radiographic imaging at Week 17

47 weeks

1 visit (in-person) at Week 17

Long-term follow-up

Participants are monitored for adverse events related to treatment up to Week 60

43 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Radiesse

Trial Overview The study is testing whether Radiesse dilute, a treatment for neck wrinkles, affects the quality of breast tissue images taken by radiographic methods like mammograms and ultrasounds.

How Is the Trial Designed?

Group I: Radiesse Experimental Treatment 1 Intervention

Participants will receive three injections of Radiesse in the Décolleté at Weeks 1, 7 and 13.

Who Is Running the Clinical Trial?

Merz North America, Inc.

Lead Sponsor

Trials

67

Recruited

10,000+

Leonard Paolillo

Merz North America, Inc.

Chief Executive Officer

Bachelor of Science in Business Administration from Manhattan College

Dr. McKinnon

Merz North America, Inc.

Chief Medical Officer since 2024

Ph.D. in Pharmacology and Toxicology from the University of Western Ontario

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07086248

A Study to Determine if RADIESSE® Dilute Treatment in ... The primary purpose of this study is to determine if treatment with Radiesse dilute in the décolleté interferes with radiographic imaging of the breast tissue.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10693750/

Starting Point for Protocols on the Use of Hyperdiluted ... The treatment was effective in improving skin thickness, laxity, and wrinkles in 95% of 30–40 year-olds, 80% of 40–60 year-olds, and 70% of >60 ...

3. withpower.com withpower.com/trial/phase-dcollet-wrinkles-6-2025-45312

Radiesse for Chest Area Imaging The primary purpose of this study is to determine if treatment with Radiesse dilute in the décolleté interferes with radiographic imaging of the breast tissue.

4. biospace.com biospace.com/press-releases/merz-aesthetics-receives-approval-from-health-canada-for-radiesse-as-an-aesthetic-injectable-for-the-treatment-of-moderate-wrinkles-in-the-decollete-area

Merz Aesthetics® Receives Approval from Health Canada ... Radiesse® is a regenerative biostimulator1 capable of regenerating multiple components of the skin tissue, resulting in healthier-looking skin,1 ...

5. fda.gov fda.gov/media/188185/download

FDA Executive Summary General Issues Panel Meeting on ... Note that the majority of serious injury reports were reported for the neck area with 162/186 (87.1%); while the décolletage/décolleté/chest ...

6. center4research.org center4research.org/medscape-fda-panel-caution-dermal-filler-decolletage/

FDA Panel Urges Caution, More Data on Dermal Filler Use ... Radiesse manufacturer, Merz Aesthetics, told the panel that, between 2018 and 2025, it received 44 reports of potential adverse events in the ...

7. thedermdigest.com thedermdigest.com/health-canada-approves-radiesse-for-moderate-wrinkles-in-the-decollete-area/

Health Canada Approves Radiesse for Moderate Wrinkles ... Health Canada Approves Radiesse for Moderate Wrinkles in the Décolleté Area ... It is a true biostimulator that has almost 20 years of safety data for the ...

8. medscape.com medscape.com/viewarticle/fda-panel-urges-caution-more-data-dermal-filler-use-2025a1000llk

FDA Panel Seeks More Data on Filler Use in Decolletage ... Radiesse manufacturer, Merz Aesthetics, told the panel that, between 2018 and 2025, it received 44 reports of potential adverse events in the ...

9. joinbeautycult.com joinbeautycult.com/blog/is-hyper-diluted-radiesse-safe-understand-benefits-and-results

Is Hyper-Diluted Radiesse Safe? - Beauty Cult Expert Approval: A panel of dermatologists and plastic surgeons reviewed its safety in 2019 and confirmed that Radiesse is highly safe when used correctly.