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

Merz Pharmaceuticals

Status

Enrolling

Conditions

Décolleté Wrinkles

Treatments

Device: Radiesse

Study type

Interventional

Funder types

Industry

Identifiers

NCT07086248

RAD-DEC-US001

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

Female

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

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.