Status:
COMPLETED
Evaluation of Radiesse® Dermal Filler for Hand Treatment
Lead Sponsor:
Merz North America, Inc.
Collaborating Sponsors:
Merz Aesthetics Inc.
Conditions:
Aging Hands
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- Has right and left hands with rating of 2 or 3 on the Merz Hand Grading Scale (MHGS) as determined by a live, masked evaluator
- Is at least 18 years of age
Exclusion
- Has history of hypertropic scarring
- Has a known bleeding disorder or receiving medication that will increase the risk of bleeding as the result of injection
- Has a known hypersensitivity to any of the components of Radiesse or local anesthesia
- Has received in past 6 months or plans to receive during the study dermal resurfacing procedure (chemical peel, dermabrasion, ablative laser resurfacing) or non-invasive skin tightening (Thermage®) in the dorsum of the hands
- Has received in past 2 weeks or plans to receive during the study prescription wrinkle therapies, topical steroids, skin irritating topical preparations, or pigmenting agents (self-tanning agents) in the dorsum of the hands
- Has had any dermal fillers or surgery in the dorsum of the hand
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT01832090
Start Date
March 1 2013
End Date
September 1 2014
Last Update
October 19 2017
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Merz Investigative Site #004
San Diego, California, United States, 92121
2
Merz Investigative Site #007
Vista, California, United States, 92083
3
Merz Investigative Site #002
Garden City, New York, United States, 11530
4
Merz Investigative Site #006
New York, New York, United States, 10022