Décolleté Wrinkles
Conditions
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.
Interventions
DEVICERadiesse
Radiesse injections diluted 1:2 with sterile saline.
Sponsors
Merz North America, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
United States
Contacts
STUDY_DIRECTORMerz Medical Expert
Merz North America, Inc.
Outcome results
None listed