Radiesse® Safety Study For the Treatment of Hands

NCT02904096 | Completed Results FDA Device

• 1 other identifier: P151009, M900311002
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Volume Loss in the Dorsum of the Hand

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects With Device-and/or Injection-related Severe Treatment-emergent Adverse Events (TEAEs) in the Grade 4 Hands Group Versus the Grade 2-3 Hands Group at Month 6

  Proportion refers to percentage of subjects with device-and/or injection-related severe TEAEs.

  Month 6

Secondary Outcomes (9)

• Proportion of Subjects With Device-and/Injection-related Severe TEAEs in the Grade 4 Hands Group Versus the Grade 2-3 Hands Group at Month 24

  Month 24

• Change From Baseline in Range of Motion (ROM) Flexion and Extension (Angle) for Metacarpophalangeal Joints in Each Hand at Month 24

  Baseline, Month 24

• Change From Baseline in Functional Dexterity in Each Hand at Month 24

  Baseline, Month 24

• Change From Baseline in Sensation to Filament Size Between Metacarpals in Each Hand at Month 24

  Baseline, Month 24

• Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24

  Baseline, Month 24

Study Arms (2)

"Grade 4 Hands" group

EXPERIMENTAL

"Grade 4 Hands" group will be subjects with hand grading of grade 4 (very severe loss of fatty tissue, marked visibility of veins and tendons in the dorsal hand). "Grade 4 Hands" group subjects will receive Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment. Subjects in "Grade 4 Hands" group can have up to three retreatments over an 18 month period.

Device: Radiesse injectable implant and 2% lidocaine HCL

"Grade 2 or 3 Hands" group

EXPERIMENTAL

"Grade 2 or 3 Hands" group will be subjects with hand grading of grade 2 or grade 3 (moderate to severe loss of fatty tissue, mild to moderate visibility of veins and tendons in the dorsal hand). "Grade 2 or 3 Hands" group subjects will receive Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment. Subjects in "Grade 2 or 3 Hands" group can have up to three retreatments over an 18 month period.

Device: Radiesse injectable implant and 2% lidocaine HCL

Interventions

Radiesse injectable implant and 2% lidocaine HCL DEVICE

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.

"Grade 2 or 3 Hands" group; "Grade 4 Hands" group

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Merz North America, Inc.: lead

Study Sites (9)

Merz Investigative Site #0010393

Sacramento, California, United States

Location

Merz Investigative Site #0010321

San Diego, California, United States

Location

Merz Investigative Site #0010358

Vista, California, United States

Location

Merz Investigative Site #0010099

West Hollywood, California, United States

Location

Merz Investigative Site #0010405

New York, New York, United States

Location

Merz Investigative Site #0010406

New York, New York, United States

Location

Merz Investigative Site #0010322

Austin, Texas, United States

Location

Merz Investigative Site #0010125

Plano, Texas, United States

Location

Merz Investigative Site #0010392

Spokane, Washington, United States

Location

Results Point of Contact

• Title: Public Disclosure Manager
• Organization: Merz Pharmaceuticals GmbH

clinicaltrials@merz.com

+49 69 1503 1

Study Officials

• Merz Medical Expert

  Merz North America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 16, 2016
• Study Start: June 10, 2016
• Primary Completion: January 9, 2019
• Study Completion: January 9, 2019
• Last Updated: January 13, 2020
• Results First Posted: January 13, 2020

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)