Radiological Evaluation of Radiesse Implantation in the Hands

Completed · Not applicable

Conditions studied: Volume Loss in the Dorsum of the Hand

In brief

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.

Key facts

Study ID

NCT02949921

Run by

Merz North America, Inc.

People needed

20

Starts

2015-12-01

Expected to finish

2018-01-02

Last updated by the study team

2023-11-29

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Merz Investigative Site #0010358 — Vista, California, United States

Full record on ClinicalTrials.gov

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