Active — Not RecruitingNot Applicable

A Study to Determine if RADIESSE® Dilute Treatment in Décolleté of Adult Women Affects Radiographic Imaging Assessments

United States30 participantsStarted 2025-07-22

Plain-language summary

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.

Who can participate

Age range

40 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants seeking improvement of moderate to severe décolleté wrinkles. * Participant is willing to undergo up to three bilateral mammograms and up to four bilateral ultrasound procedures. Exclusion Criteria: * Any pre-existing serious disease or disorder of the breast tissue that may confound interpretation of radiographic and/or ultrasound imaging (example., participants with a history of breast cancer or an immediate family history of breast cancer \[that is., mother, sister, and/or daughter\], pathogenic or likely pathogenic breast cancer (BRCA) gene variant, calcifications and/or microcalcifications detected on previous mammography \[up to three years prior to study start, if available\]). * Present uncontrolled malignant disease. * Any condition that would caution against receiving additional radiation exposure in the breasts. * Any previous surgery, including plastic surgery or permanent surgical implant, or previous non-surgical treatment in the planned in the treatment area and in the breasts.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Any Interference of Radiesse Dilute in Either Breast Observed in Breast Ultrasound or Mammogram Images at Week 17, As Assessed By an Adjudication Committee Composed of Two Board-certified Radiologists

Timeframe: Week 17

Trial details

NCT IDNCT07086248

SponsorMerz North America, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-26

View on ClinicalTrials.gov More Décolleté Wrinkles trials