RECRUITING

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

Description

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.

Study Overview

Study Details

Study overview

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.

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

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

Condition
Décolleté Wrinkles
Intervention / Treatment

-

Contacts and Locations

Alpharetta

Merz Investigative Site, Alpharetta, Georgia, United States, 30005

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

40 Years to 65 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merz North America, Inc.,

Merz Medical Expert, STUDY_DIRECTOR, Merz North America, Inc.

Study Record Dates

2026-10