- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02949921
Radiological Evaluation of Radiesse Implantation in the Hands
Radiesse® Post Approval Safety Study - Radiological Evaluation of Implantation in the Hands
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Vista, California, United States
- Merz Investigative Site #0010358
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Has hands rating 2, 3, or 4 on the validated Merz Hand Grading Scale (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.
Exclusion Criteria:
- 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 adverse events (AEs).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: "Grade 4 Hands" group
"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.
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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.
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Experimental: "Grade 2 or 3 Hands" group
"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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 1
Time Frame: Month 1
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Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones.
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Month 1
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Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 6
Time Frame: Month 6
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Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones.
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Month 6
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Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 12
Time Frame: Month 12
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Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones.
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Month 12
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Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 24
Time Frame: Month 24
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Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones.
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Month 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Reporting One or More Device or Injection-related Severe Adverse Events (AEs) at Months 1 and 6
Time Frame: Months 1 and 6
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Months 1 and 6
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Michigan Hand Outcomes Questionnaire (MHQ) Scores
Time Frame: Baseline, Months 1, 6, 7, 12, 13, 18, 19 and 24
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The MHQ is a hand-specific outcomes instrument that measures outcomes of participants with conditions of, or injury to, the hand or wrist.
The MHQ contains six domains: overall hand function, activities of daily living, work performance, pain, aesthetics and satisfaction.
For this study, MHQ overall hand function and MHQ pain domains were evaluated.
Scores for both scales range from 0-100.
Higher MHQ hand function scores denote better hand performance whereas higher MHQ pain scores denote more pain.
MHQ minimal clinically important differences were defined as score changes greater than an 11-point increase for the pain domain and greater than a 13-point decrease for the function domain.
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Baseline, Months 1, 6, 7, 12, 13, 18, 19 and 24
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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
Time Frame: Months 1 and 6
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The MHGS was used to measure clinical efficacy of the Radiesse hand treatments by a masked evaluator performing live, dorsal hand assessments.
The MHGS was an ordinal scale; therefore, ratings were made based on a "snap-shot" at a specific study time point.
A measure of successful or improved treatment effect was demonstrated by a decrease in MHGS score.
MHGS had 5 categories, where: 0 (no loss of fatty tissue); 1 (mild loss of fatty tissue; slight visibility of veins); 2 (moderate loss of fatty tissue; mild visibility of veins and tendons); 3 (severe loss of fatty tissue; moderate visibility of veins and tendons); 4(very severe loss of fatty tissue; marked visibility of veins and tendons).
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Months 1 and 6
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Number of Participants With >=1 Point Improvement on the MHGS in Both Hands Following Retreatment at Months 7 and 12
Time Frame: Months 7 and 12
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The MHGS was used to measure clinical efficacy of the Radiesse hand treatments by a masked evaluator performing live, dorsal hand assessments.
The MHGS was an ordinal scale; therefore, ratings were made based on a "snap-shot" at a specific study time point.
A measure of successful or improved treatment effect was demonstrated by a decrease in MHGS score.
MHGS had 5 categories, where: 0 (no loss of fatty tissue); 1 (mild loss of fatty tissue; slight visibility of veins); 2 (moderate loss of fatty tissue; mild visibility of veins and tendons); 3 (severe loss of fatty tissue; moderate visibility of veins and tendons); 4(very severe loss of fatty tissue; marked visibility of veins and tendons).
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Months 7 and 12
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Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6
Time Frame: Months 1 and 6
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The GAIS is a 7-point scale.
The 7-point scale are as follows: +3 (very much improved); +2 (much improved); +1 (improved); 0 (no change); -1 (worse); -2 (much worse); -3 (very much worse).
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Months 1 and 6
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Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12
Time Frame: Months 7 and 12
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The GAIS is a 7-point scale.
The 7-point scale are as follows: +3 (very much improved); +2 (much improved); +1 (improved); 0 (no change); -1 (worse); -2 (much worse); -3 (very much worse).
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Months 7 and 12
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Peter Kreymerman, MD,FACS, Study Director
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- P151010, M900311003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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