Evaluation of Radiesse® Dermal Filler for Hand Treatment

• ClinicalTrials.gov Identifier: NCT01832090
• Recruitment Status: Completed
• First Posted: April 15, 2013
• Results First Posted: October 19, 2017
• Last Update Posted: October 19, 2017
• Sponsor: Merz North America, Inc.
• Collaborator: Merz Aesthetics Inc.
• Information provided by (Responsible Party): Merz North America, Inc.

Study Description

Brief Summary:

The purpose of this study is to assess the safety and effectiveness of Radiesse® Injectable Dermal Filler for hand treatment.

Condition or disease	Intervention/treatment	Phase
Aging Hands	Device: Radiesse® Injectable Dermal Filler	Not Applicable

Detailed Description:

This is a prospective, randomized, masked, controlled study to investigate the effectiveness of Radiesse® Dermal Filler for hand treatment, comprised of a 3-month main study followed by an open-label extension (OLEX) study through 12 months. At 3 months, untreated controls received Radiesse Dermal Filler for hand treatment and were followed for the remainder of the study. All study subjects were eligible for retreatment 6 months after initial treatment, and all subjects were followed through 12 months from study enrollment in the OLEX.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 118 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase 4, Evaluation of Radiesse® Dermal Filler for Hand Treatment
• Study Start Date: March 2013
• Actual Primary Completion Date: August 2014
• Actual Study Completion Date: September 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Radiesse® Injectable Dermal Filler; Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)	Device: Radiesse® Injectable Dermal Filler; Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
Active Comparator: Delayed Treatment; Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months	Device: Radiesse® Injectable Dermal Filler; Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.

Outcome Measures

Primary Outcome Measures :

1. Mean Change on Merz Hand Grading Scale (MHGS), by Hand [ Time Frame: 3 months from baseline ]

   To evaluate the efficacy of Radiesse for hand treatment as measured by a mean change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3 months, by hand, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.

   MHGS categories are as follows:

   0 = no loss of fatty tissue;

   1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons.

2. ≥ 1-point Change on the 5-point Merz Hand Grading Scale (MHGS), by Hand [ Time Frame: 3 months from baseline ]

   To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3 months, by hand, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.

   MHGS categories are as follows:

   0 = no loss of fatty tissue;

   1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons.

3. ≥ 1-point Change on the 5-point Merz Hand Grading Scale (MHGS), by Subject [ Time Frame: 3 months from baseline ]

   To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3 months, by subject, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.

   MHGS categories are as follows:

   0 = no loss of fatty tissue;

   1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons.

Secondary Outcome Measures :

1. Mean Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years [ Time Frame: 3 months from baseline ]

   To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3 months, by hand, among treated subjects and untreated controls, stratified by age < 60 years or ≥ 60 years. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.

   MHGS categories are as follows:

   0 = no loss of fatty tissue;

   1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons.

2. ≥ 1-point Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years [ Time Frame: 3 months from baseline ]

   To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3 months, by hand, among treated subjects and untreated controls, stratified by age < 60 years or ≥ 60 years. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.

   MHGS categories are as follows:

   0 = no loss of fatty tissue;

   1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons.

3. ≥ 1-point Change on Merz Hand Grading Scale (MHGS), by Subject, With Subjects Stratified by Age < 60 Years or ≥ 60 Years [ Time Frame: 3 months from baseline ]

   To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3 months, by subject, among treated subjects and untreated controls, stratified by age < 60 years or ≥ 60 years. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.

   MHGS categories are as follows:

   0 = no loss of fatty tissue;

   1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons.

4. Evenness in the Left Hand Versus the Right Hand Using the Merz Hand Grading Scale (MHGS) Among the Original Treatment Group Only [ Time Frame: 3 months from baseline ]

   To evaluate the efficacy of Radiesse for hand treatment by comparing the evenness in the left hand versus the right hand at 3 months using the 5-point Merz Hand Grading Scale (MHGS) among the original treatment group only. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.

   MHGS categories are as follows:

   0 = no loss of fatty tissue;

   1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons.

5. Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group Only [ Time Frame: 3 months from baseline ]
   To evaluate the efficacy of Radiesse for hand treatment by evaluating subject-reported, live Global Aesthetic Improvement Scale (GAIS) ratings at 3 months when compared to baseline among the original treatment group only
6. Mean Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects Without Retreatment [ Time Frame: 3, 6, 9, and 12 months from baseline ]

   To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3, 6, 9, and 12 months, by hand, among all treated subjects without retreatment. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.

   MHGS categories are as follows:

   0 = no loss of fatty tissue;

   1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons.

7. Mean Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects With Retreatment [ Time Frame: 3, 6, 9, and 12 months from baseline ]

   To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3, 6, 9, and 12 months, by hand, among all treated subjects receiving retreatment. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.

   MHGS categories are as follows:

   0 = no loss of fatty tissue;

   1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons.

8. ≥ 1-point Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects With and Without Retreatment [ Time Frame: 3, 6, 9, and 12 months from baseline ]

   To evaluate the efficacy of Radiesse for hand treatment as measured by ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3, 6, 9 and 12 months, by hand, among treated subjects with and without retreatment. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.

   MHGS categories are as follows:

   0 = no loss of fatty tissue;

   1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons.

9. ≥ 1-point Change on the Merz Hand Grading Scale (MHGS), by Subject, Among All Treated Subjects With and Without Retreatment [ Time Frame: 3, 6, 9, and 12 months from baseline ]

   To evaluate the efficacy of Radiesse for hand treatment as measured by ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3, 6, 9, and 12 months, by subject, among treated subjects with and without retreatment. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.

   MHGS categories are as follows:

   0 = no loss of fatty tissue;

   1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons.

10. Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment [ Time Frame: 3, 6, 9, and 12 months from baseline ]
    To evaluate the efficacy of Radiesse for hand treatment as measured by live, subject-completed Global Aesthetic Improvement Scale (GAIS) scores between baseline and 3, 6, 9, and 12 months, by subject, among treated subjects with and without retreatment

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, California

Merz Investigative Site #004

San Diego, California, United States, 92121

Merz Investigative Site #007

Vista, California, United States, 92083

United States, New York

Merz Investigative Site #002

Garden City, New York, United States, 11530

Merz Investigative Site #006

New York, New York, United States, 10022

United States, Tennessee

Merz Investigative Site #003

Nashville, Tennessee, United States, 37215

United States, Texas

Merz Investigative Site #001

Plano, Texas, United States, 75093

Sponsors and Collaborators

Merz North America, Inc.

Merz Aesthetics Inc.

More Information

• Responsible Party: Merz North America, Inc.
• ClinicalTrials.gov Identifier: NCT01832090
• Other Study ID Numbers: P110607
• First Posted: April 15, 2013
• Results First Posted: October 19, 2017
• Last Update Posted: October 19, 2017
• Last Verified: September 2017

Keywords provided by Merz North America, Inc.:

aging; hands