Evaluation of Radiesse® Dermal Filler for Hand Treatment

NCT01832090 | Completed Results

• 1 other identifier: P110607
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Aging Hands

Keywords

aging; hands

Outcome Measures

Primary Outcomes (3)

• Mean Change on Merz Hand Grading Scale (MHGS), by Hand

  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.

  3 months from baseline

• ≥ 1-point Change on the 5-point Merz Hand Grading Scale (MHGS), by Hand

  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 months from baseline

• ≥ 1-point Change on the 5-point Merz Hand Grading Scale (MHGS), by Subject

  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.

  3 months from baseline

Secondary Outcomes (10)

• Mean Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years

  3 months from baseline

• ≥ 1-point Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years

  3 months from baseline

• ≥ 1-point Change on Merz Hand Grading Scale (MHGS), by Subject, With Subjects Stratified by Age < 60 Years or ≥ 60 Years

  3 months from baseline

• Evenness in the Left Hand Versus the Right Hand Using the Merz Hand Grading Scale (MHGS) Among the Original Treatment Group Only

  3 months from baseline

• Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group Only

  3 months from baseline

Study Arms (2)

Radiesse® Injectable Dermal Filler

EXPERIMENTAL

Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)

Device: Radiesse® Injectable Dermal Filler

Delayed Treatment

ACTIVE COMPARATOR

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

Interventions

Radiesse® Injectable Dermal Filler DEVICE

Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.

Delayed Treatment; Radiesse® Injectable Dermal Filler

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merz North America, Inc.: lead
• Merz Aesthetics Inc.: collaborator

Study Sites (6)

Merz Investigative Site #004

San Diego, California, 92121, United States

Location

Merz Investigative Site #007

Vista, California, 92083, United States

Location

Merz Investigative Site #002

Garden City, New York, 11530, United States

Location

Merz Investigative Site #006

New York, New York, 10022, United States

Location

Merz Investigative Site #003

Nashville, Tennessee, 37215, United States

Location

Merz Investigative Site #001

Plano, Texas, 75093, United States

Location

Results Point of Contact

• Title: Ashlee Duncan
• Organization: Merz North America, Inc.

ashlee.duncan@merz.com

984-222-6040

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2013
• First Posted: April 15, 2013
• Study Start: March 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 19, 2017
• Results First Posted: October 19, 2017

Record last verified: 2017-09

Locations

US (6)