RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official 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

Quick Facts

Study Start:2025-07-22

Study Completion:2026-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07086248

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.

Ages Eligible for Study:40 Years to 65 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Public Disclosure Manager

CONTACT

+1 984-301-3095

Aesthetic.Trials@merz.com

Principal Investigator

Merz Medical Expert

STUDY_DIRECTOR

Merz North America, Inc.

Study Locations (Sites)

Merz Investigative Site

Alpharetta, Georgia, 30005

United States

Collaborators and Investigators

Sponsor: Merz North America, Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-22

Study Completion Date2026-10

Study Record Updates

Study Start Date2025-07-22

Study Completion Date2026-10

Terms related to this study

Additional Relevant MeSH Terms

Décolleté Wrinkles