N/A
Completed N=20
Radiological Evaluation of Radiesse Implantation in the Hands
Volume Loss in the Dorsum of the Hand
Source: ClinicalTrials.gov NCT02949921 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 1 — 0; 0 participants
Summary
The objective of this study is to provide a preliminary assessment of the radiographic appearance of Radiesse material that has been injected into the dorsum of the hands.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 1 |
0; 0 | — |
| PRIMARY Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 6 |
0; 0 | — |
| PRIMARY Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 12 |
— | — |
| PRIMARY Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 24 |
0; 0 | — |
| SECONDARY Percentage of Participants Reporting One or More Device or Injection-related Severe Adverse Events (AEs) at Months 1 and 6 |
0; 10.0; 0; 10.0 | — |
| SECONDARY Michigan Hand Outcomes Questionnaire (MHQ) Scores |
96.5; 94.0; 2.0; 4.0; 99.0; 96.5 | — |
| SECONDARY Number of Participants With Greater Than or Equal to (>=) 1 Point Improvement on the MHGS in Both Hands After Initial Treatment at Months 1 and 6 |
10; 10; 8; 9 | — |
| SECONDARY Number of Participants With >=1 Point Improvement on the MHGS in Both Hands Following Retreatment at Months 7 and 12 |
7; 4; 5; 3 | — |
| SECONDARY Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6 |
60.0; 60.0; 60.0; 60.0; 10.0; 40.0 | — |
| SECONDARY Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12 |
57.1; 75.0; 57.1; 75.0; 28.6; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Has hands rating 2, 3, or 4 on the validated Merz Hand Grading Scale (MHGS) as determined by a live, masked evaluator.
- Is at least 22 years of age.
- Understands and accepts the obligation not to receive any other procedures in the dorsum of the hands through the end of the study.
Exclusion Criteria
- Was a participant in the Radiesse hands pre-market clinical study.
- Has been treated with fat injections or Radiesse in the hands, has hand deformities, or has received surgery in the dorsum of the hands.
- Has any medical condition with the potential to interfere with the study or increase the risk of adverse events (AEs).
Data sourced from ClinicalTrials.gov (NCT02949921). 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.