N/A
N=101
Evaluation of Radiesse® Dermal Filler for Hand Rejuvenation
Aging Hands
Bottom Line
View on ClinicalTrials.gov: NCT01004107 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand — 2.54; 2.44; 1.72; 2.44 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
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand |
2.51; 1.71; 1.95; 1.77; 1.91; NA | <0.0001 sig |
| PRIMARY ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Hand |
66.2; 56.2; 57.7; 57.3 | — |
| PRIMARY ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Subject |
51.5; 35.7; 37.8; 34.7 | — |
| SECONDARY Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand |
2.51; 1.71; 1.95; 1.77; 1.91; NA | <0.0001 sig |
| SECONDARY ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Hand |
66.2; 56.2; 57.7; 57.3 | — |
| SECONDARY ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Subject |
51.5; 35.7; 37.8; 34.7 | — |
| SECONDARY Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group and Untreated Controls Only |
15.1; 4.0; 45.4; 8.0; 30.3; 26.0 | <0.0001 sig |
| SECONDARY Global Aesthetic Improvement Scale (GAIS) Ratings of at Least "Improved" Among the Original Treatment Group Only |
84.2; 24.0 | <0.0001 sig |
| SECONDARY Global Aesthetic Improvement Scale (GAIS) Ratings, by Hand |
15.2; 8.7; 0.5; 0.0; 43.9; 29.1 | — |
| SECONDARY Global Aesthetic Improvement Scale (GAIS) Ratings of at Least "Improved" Over Study |
78.8; 62.2; 29.6; 28.0 | — |
| SECONDARY Physician Satisfaction Evaluation |
26.3; 30.6; 18.4; 32.0; 59.6; 57.1 | — |
| SECONDARY Patient Satisfaction Evaluation |
33.3; 29.6; 25.5; 30.7; 44.4; 45.9 | — |
| SECONDARY Patient Satisfaction Evaluation: Likelihood to Return for Future Radiesse Treatments |
29.3; 34.7; 28.6; 36.0; 36.4; 31.6 | — |
| SECONDARY Mean Hand Function Rating During Prior Week |
1.21; 1.14; 1.09; 1.06; 1.12; 1.22 | — |
| SECONDARY Difficulty Performing Activities During Prior Week |
1.01; 1.05; 1.02; 1.05; 1.05; 1.08 | — |
| SECONDARY Difficulty Performing Activities During Prior Week, Both Hands |
1.20; 1.18; 1.13; 1.11; 1.09; 1.14 | — |
| SECONDARY Normal Work During Prior Week Evaluation |
4.80; 4.93; 4.88; 4.99; 4.96; 4.79 | — |
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 a rating of 3 or 4 on the Busso Hand Volume Severity Scale (BHVSS) as determined by the treating physician
- Signs a written informed consent
- Understands and accepts the obligation not to receive any other procedures in the dorsum of the hands through 12 month follow up
- Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits
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 used predefined products or treatments on the dorsum of the hand within last 4 weeks or intends to use during study
- Has had any dermal fillers or surgery in the dorsum of the hand
- Is a female of child bearing potential and not using medically effective birth control or is pregnant or lactating
Data sourced from ClinicalTrials.gov (NCT01004107). 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.