An interventional study of Radiesse in Décolleté Wrinkles, sponsored by Merz North America, Inc.. Active, not recruiting at 1 site in United States. Open to female participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Merz North America, Inc. (part of Merz Pharma) · Not applicable, Interventional, and Treatment
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.
Merz North America, Inc. is the lead sponsor of 53 studies on the registry; 2 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 19 (95%) have results posted.
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Exclusion Criteria:
Participants will receive three injections of Radiesse in the Décolleté at Weeks 1, 7 and 13.
Device: Radiesse
Radiesse injections diluted 1:2 with sterile saline.
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).
Time frame: Week 17
Occurrence of Adverse Events (AEs) Related to Treatment With Radiesse Dilute, as Reported By the Treating Investigator Throughout the Study
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.
Time frame: Baseline up to Week 60
Plan to share: No
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This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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