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

NCT07086248 | Active Not Recruiting FDA Device

• 1 other identifier: RAD-DEC-US001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Décolleté Wrinkles

Outcome Measures

Primary Outcomes (1)

• 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

  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).

  Week 17

Secondary Outcomes (1)

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

  Baseline up to Week 60

Study Arms (1)

Radiesse

EXPERIMENTAL

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

Device: Radiesse

Interventions

Radiesse DEVICE

Radiesse injections diluted 1:2 with sterile saline.

Radiesse

Eligibility Criteria

• Age: 40 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merz North America, Inc.: lead

Study Sites (1)

Merz Investigative Site

Alpharetta, Georgia, 30005, United States

Location

Study Officials

• Merz Medical Expert

  Merz North America, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 25, 2025
• Study Start: July 22, 2025
• Primary Completion: January 26, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)