Clinical trial NCT02904096: Radiesse® Safety Study For the Treatment of Hands
Official title: Radiesse® Post Approval Safety Study For the Treatment of Hands With Moderate to Very Severe Dorsal Volume Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Volume Loss in the Dorsum of the Hand
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2016-09-16
Enrollment: 256
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Has hands rating 2, 3, or 4 on the validated MHGS as determined by a live, masked evaluator.
2. Is at least 22 years of age.
3. Understands and accepts the obligation not to receive any other procedures in the dorsum of the hands through the end of the study.
4. Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits and meet all study requirements.

Exclusion Criteria:

1. Was a participant in the Radiesse hands pre-market clinical study
2. Has been treated with fat injections or Radiesse in the hands, has hand deformities, or has received surgery in the dorsum of the hands.
3. Has any medical condition with the potential to interfere with the study or increase the risk of AEs.

Primary outcomes:
measure: 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
timeFrame: Month 6
Secondary outcomes:
measure: 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
timeFrame: Month 24
measure: Change From Baseline in Range of Motion (ROM) Flexion and Extension (Angle) for Metacarpophalangeal Joints in Each Hand at Month 24
timeFrame: Baseline, Month 24
measure: Change From Baseline in Functional Dexterity in Each Hand at Month 24
timeFrame: Baseline, Month 24
measure: Change From Baseline in Sensation to Filament Size Between Metacarpals in Each Hand at Month 24
timeFrame: Baseline, Month 24
measure: Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24
timeFrame: Baseline, Month 24
measure: Number of Subjects With MHGS Scores Greater Than or Equal (>=) to 1-point Improvement From Baseline in Both Hands at Month 3 After Initial Treatment
timeFrame: Month 3
measure: Number of Subjects With MHGS >=1-point Improvement Following 3 Months After Retreatment at Months 9, 15 and 21
timeFrame: Months 9, 15, and 21
measure: Number of Subjects With Any Improvement on Global Aesthetic Improvement Scale (GAIS) From Baseline in Both Hands at Month 3 After Initial Treatment
timeFrame: Month 3
measure: Number of Subjects With Any Improvement on GAIS Following 3 Months After Retreatment at Months 9, 15 and 21
timeFrame: Months 9, 15, and 21
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Merz Investigative Site #0010393
state: California
city: San Diego
country: United States
facility: Merz Investigative Site #0010321
state: California
city: Vista
country: United States
facility: Merz Investigative Site #0010358
state: California
city: West Hollywood
country: United States
facility: Merz Investigative Site #0010099
state: California
city: New York
country: United States
facility: Merz Investigative Site #0010405
state: New York
city: New York
country: United States
facility: Merz Investigative Site #0010406
state: New York
city: Austin
country: United States
facility: Merz Investigative Site #0010322
state: Texas
city: Plano
country: United States
facility: Merz Investigative Site #0010125
state: Texas
city: Spokane
country: United States
facility: Merz Investigative Site #0010392
state: Washington
Study officials:
affiliation: Merz North America, Inc.
name: Merz Medical Expert
role: STUDY_DIRECTOR
References: