N/A
Completed N=152
Evaluation of the Effectiveness and Safety of Diluted RADIESSE® in the Treatment of Décolleté Wrinkles
Décolleté Wrinkles
Source: ClinicalTrials.gov NCT05163353 ↗
Enrolled (actual)
152
Serious AEs
1.3%
Results posted
Oct 2025
Primary outcomePrimary: Percentage of Responders on Merz Aesthetic Scale (MAS) Décolleté Wrinkles - at Rest at Week 24 — 71.2; 6.3 percentage of subjects
Summary
Trial to confirm the effectiveness and demonstrate the safety of treatment with diluted Radiesse for correction of Décolleté Wrinkles.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Responders on Merz Aesthetic Scale (MAS) Décolleté Wrinkles - at Rest at Week 24 |
71.2; 6.3 | — |
| SECONDARY Percentage of Responders on MAS Décolleté Wrinkles - Dynamic at Week 24 |
65.8; 16.0 | — |
| SECONDARY Percentage of Subjects With Any Improvement on Investigator Global Aesthetic Improvement Scale (iGAIS) at Week 24 |
92.6 | — |
| SECONDARY Percentage of Subjects With Any Improvement on Subject Global Aesthetic Improvement Scale (sGAIS) at Week 24 |
87.4 | — |
| SECONDARY Number of Subjects With Treatment-emergent Adverse Events (TEAEs) Related to Radiesse |
16; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Female between ≥ 30 and ≤ 65 years old at the time of the screening.
- Subjects seeking improvement of décolleté wrinkles.
Exclusion Criteria
- Any previous surgery, including plastic surgery or permanent surgical implant in the treatment area.
- Previous treatment with collagen fillers, calcium hydroxylapatite, and/or long-lasting hyaluronic acid (HA) fillers in the décolleté, or with other HA fillers in the décolleté.
- Previous treatment with botulinum toxin, ablative or fractional laser, microdermabrasion, microneedling, chemical peels, and/or non-invasive skin tightening in the décolleté.
Data sourced from ClinicalTrials.gov (NCT05163353). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.