Radiesse® Safety Study For the Treatment of Hands

Completed · Not applicable

Conditions studied: Volume Loss in the Dorsum of the Hand

In brief

The primary objective of this study is to evaluate the safety of Radiesse implantation for very severe volume loss in the dorsum of the hand at 6 months after treatment.

Key facts

Study ID

NCT02904096

Run by

Merz North America, Inc.

People needed

256

Starts

2016-06-10

Expected to finish

2019-01-09

Last updated by the study team

2020-01-13

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 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.
• Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits and meet all study requirements.

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 AEs.

Where it is running

• Merz Investigative Site #0010393 — Sacramento, California, United States
• Merz Investigative Site #0010321 — San Diego, California, United States
• Merz Investigative Site #0010358 — Vista, California, United States
• Merz Investigative Site #0010099 — West Hollywood, California, United States
• Merz Investigative Site #0010405 — New York, New York, United States
• Merz Investigative Site #0010406 — New York, New York, United States
• Merz Investigative Site #0010322 — Austin, Texas, United States
• Merz Investigative Site #0010125 — Plano, Texas, United States
• Merz Investigative Site #0010392 — Spokane, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.