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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Décolleté Wrinkles

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Merz Investigative Site

Alpharetta, Georgia, 30005, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiesse

Device

Radiesse injections diluted 1:2 with sterile saline.

Primary outcomes

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

Time frame: Week 17

Interference is defined as a "Yes" response to questions (Q) Q2, Q3, Q5, or Q6 by at least one adjudication committee member. The questionnaire includes six questions assessing product visibility on breast imaging and its impact on diagnostic interpretation. For ultrasound: Q1 asks if the product is visible on the assessed breast ultrasound image(s) (Yes/No). If visible, Q2 asks if it inhibits accurate breast tissue assessment (Yes/No), and Q3 asks if it may cause a false positive leading to additional screening or unnecessary biopsies (Yes/No). For mammography: Q4 asks if the product is visible on the assessed mammogram image(s) (Yes/No). If visible, Q5 asks if it inhibits accurate breast tissue assessment (Yes/No), and Q6 asks if it may cause a false positive leading to further screening or unnecessary biopsies (Yes/No).

Secondary outcomes

Occurrence of Adverse Events (AEs) Related to Treatment With Radiesse Dilute, as Reported By the Treating Investigator Throughout the Study

Time frame: Baseline up to Week 60

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE is considered to be related if a causal relationship between Radiesse Dilute and the AE is at least reasonably possible.

Sponsors and collaborators

Lead sponsor

Merz North America, Inc.

Industry

Registry information

Official study title

An Open-label, Multicenter, Single-arm, Uncontrolled Safety Study to Assess Radiographic Imaging Following Treatment With RADIESSE® Dilute in the Décolleté in Adult Females in the United States

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jul 25, 2025
Registry last updated: May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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