NCT01832090

Evaluation of Radiesse® Dermal Filler for Hand Treatment

Phase 4, Evaluation of Radiesse® Dermal Filler for Hand Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Merz North America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety and effectiveness of Radiesse® Injectable Dermal Filler for hand treatment.

Detailed description

This is a prospective, randomized, masked, controlled study to investigate the effectiveness of Radiesse® Dermal Filler for hand treatment, comprised of a 3-month main study followed by an open-label extension (OLEX) study through 12 months. At 3 months, untreated controls received Radiesse Dermal Filler for hand treatment and were followed for the remainder of the study. All study subjects were eligible for retreatment 6 months after initial treatment, and all subjects were followed through 12 months from study enrollment in the OLEX.

Conditions

• Aging Hands

Interventions

Type	Name	Description
DEVICE	Radiesse® Injectable Dermal Filler	Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-08-01
• Completion: 2014-09-01
• First posted: 2013-04-15
• Last updated: 2017-10-19
• Results posted: 2017-10-19

Locations

6 sites across 1 country: United States