NCT02904096

Radiesse® Safety Study For the Treatment of Hands

Radiesse® Post Approval Safety Study For the Treatment of Hands With Moderate to Very Severe Dorsal Volume Loss

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Merz North America, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This is a 2-year post approval safety (PAS) study evaluating the Adverse Event (AE) rate of Merz Hand Grading Scale (MHGS) baseline grade 4 hands (Group A) compared to the AE rate of MHGS baseline grade 2-3 hands (Group B). Subjects will be recruited at each site with the intention to have an equal number of subjects in Group A and Group B. All subjects will receive an initial Radiesse hand treatment in both hands, and up to 3 retreatments in the study. Hands will be assessed by evaluators on the MHGS who will be blinded to group, treatment details, time since last treatment, and number of retreatments.

Conditions

• Volume Loss in the Dorsum of the Hand

Interventions

Type	Name	Description
DEVICE	Radiesse injectable implant and 2% lidocaine HCL	Radiesse injectable implant injected in small boluses (0.2-0.5cc/bolus). No more than 0.5cc per bolus. No more than 3 cc (2 syringes) will be injected per hand.

Timeline

• Start date: 2016-06-10
• Primary completion: 2019-01-09
• Completion: 2019-01-09
• First posted: 2016-09-16
• Last updated: 2020-01-13
• Results posted: 2020-01-13

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study