N/A
N=118
Evaluation of Radiesse® Dermal Filler for Hand Treatment
Aging Hands
Bottom Line
View on ClinicalTrials.gov: NCT01832090 ↗Enrolled (actual)
118
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Mean Change on Merz Hand Grading Scale (MHGS), by Hand — 2.6; 2.6; 1.5; 2.6 units on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Radiesse® Injectable Dermal Filler (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merz North America, Inc.
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change on Merz Hand Grading Scale (MHGS), by Hand |
2.6; 2.6; 1.5; 2.6; -1.1; -0.1 | <0.0001 sig |
| PRIMARY ≥ 1-point Change on the 5-point Merz Hand Grading Scale (MHGS), by Hand |
77.1; 5.2 | <0.0001 sig |
| PRIMARY ≥ 1-point Change on the 5-point Merz Hand Grading Scale (MHGS), by Subject |
75.3; 3.4 | <0.0001 sig |
| SECONDARY Mean Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years |
2.5; 2.5; 2.7; 2.7; 1.4; 2.4 | <0.0001 sig |
| SECONDARY ≥ 1-point Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years |
78.4; 8.3; 72.2; 0.0 | >0.05 |
| SECONDARY ≥ 1-point Change on Merz Hand Grading Scale (MHGS), by Subject, With Subjects Stratified by Age < 60 Years or ≥ 60 Years |
76.1; 5.6; 72.2; 0.0 | >0.05 |
| SECONDARY Evenness in the Left Hand Versus the Right Hand Using the Merz Hand Grading Scale (MHGS) Among the Original Treatment Group Only |
84.7; 15.3; 0 | — |
| SECONDARY Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group Only |
31.8; 44.1; 21.8; 2.4; 0.0; 97.6 | — |
| SECONDARY Mean Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects Without Retreatment |
2.5; 1.3; 1.3; 1.4; 1.7 | <0.0001 sig |
| SECONDARY Mean Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects With Retreatment |
2.6; 1.5; 1.7; 1.4; 1.3 | <0.0001 sig |
| SECONDARY ≥ 1-point Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects With and Without Retreatment |
83.1; 88.3; 73.6; 71.7 | — |
| SECONDARY ≥ 1-point Change on the Merz Hand Grading Scale (MHGS), by Subject, Among All Treated Subjects With and Without Retreatment |
82.1; 88.5; 71.4; 68.2 | — |
| SECONDARY Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment |
29.2; 41.6; 32.9; 11.4; 44.2; 43.4 | — |
Summary
The purpose of this study is to assess the safety and effectiveness of Radiesse® Injectable Dermal Filler for hand treatment.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01832090). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.