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Completed

NCT Number: NCT01832090

Evaluation of Radiesse® Dermal Filler for Hand Treatment

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

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Key information

Conditions

Aging Hands

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Merz Investigative Site #004, San Diego, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiesse® Injectable Dermal Filler

Device

Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Merz North America, Inc.

Industry

Collaborators

  • Merz Aesthetics Inc.

Registry information

Official study title

Phase 4, Evaluation of Radiesse® Dermal Filler for Hand Treatment

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 15, 2013
Registry last updated
Oct 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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