Clinical trial NCT02949921: Radiological Evaluation of Radiesse Implantation in the Hands
Official title: Radiesse® Post Approval Safety Study - Radiological Evaluation of Implantation in the Hands
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: 2016-10-31
Enrollment: 20
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 objective of this study is to provide a preliminary assessment of the radiographic appearance of Radiesse material that has been injected into the dorsum of the hands.

Detailed description: Radiesse dermal filler is radiopaque and shows no overt radiographic safety concerns in a study of 58 patients after facial implantation, with Radiesse not always visible on plain X-rays.

This Post Approval Safety study will evaluate if there are concerns after Radiesse implantation in the dorsum of hands, specifically if implantation interferes with radiological assessment by obscuring the bones of the hand.

Hands will be scored according to the 5 point Merz Hand Grading Scale (MHGS), which ranges from 0 (No loss of fatty tissue) to 4 (Very severe loss of fatty tissue; marked visibility of veins and tendons).

Eligibility criteria: Inclusion Criteria:

1. Has hands rating 2, 3, or 4 on the validated Merz Hand Grading Scale (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.

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 adverse events (AEs).

Primary outcomes:
measure: Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 1
timeFrame: Month 1
measure: Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 6
timeFrame: Month 6
measure: Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 12
timeFrame: Month 12
measure: Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 24
timeFrame: Month 24
Secondary outcomes:
measure: Percentage of Participants Reporting One or More Device or Injection-related Severe Adverse Events (AEs) at Months 1 and 6
timeFrame: Months 1 and 6
measure: Michigan Hand Outcomes Questionnaire (MHQ) Scores
timeFrame: Baseline, Months 1, 6, 7, 12, 13, 18, 19 and 24
measure: Number of Participants With Greater Than or Equal to (>=) 1 Point Improvement on the MHGS in Both Hands After Initial Treatment at Months 1 and 6
timeFrame: Months 1 and 6
measure: Number of Participants With >=1 Point Improvement on the MHGS in Both Hands Following Retreatment at Months 7 and 12
timeFrame: Months 7 and 12
measure: Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6
timeFrame: Months 1 and 6
measure: Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12
timeFrame: Months 7 and 12
Other outcomes:
Locations:
city: Vista
country: United States
facility: Merz Investigative Site #0010358
state: California
Study officials:
affiliation: Study Director
name: Peter Kreymerman, MD,FACS
role: STUDY_DIRECTOR
References:
citation: Moradi A, Ethakovic R, Odena G. Aesthetic Implantation of Calcium Hydroxylapatite Does Not Interfere With Radiological Assessment of Bones in the Dorsum of the Hands. Aesthet Surg J. 2023 May 15;43(6):696-703. doi: 10.1093/asj/sjac344.