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Evaluation of Radiesse® Dermal Filler for Hand Rejuvenation

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ClinicalTrials.gov Identifier: NCT01004107
Recruitment Status : Completed
First Posted : October 29, 2009
Results First Posted : July 13, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Merz North America, Inc.

Tracking Information
First Submitted Date  ICMJE October 27, 2009
First Posted Date  ICMJE October 29, 2009
Results First Submitted Date  ICMJE October 6, 2016
Results First Posted Date  ICMJE July 13, 2018
Last Update Posted Date July 13, 2018
Study Start Date  ICMJE October 2008
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2017)
  • Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand [ Time Frame: 3 months from baseline ]
    To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by hand, among treated subjects and untreated controls. Ratings were completed by three, blinded evaluators. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score. Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows: 4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest; 1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.
  • ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), 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 Busso Hand Volume Severity Scale (BHVSS) 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 BHVSS score. Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows: 4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest; 1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.
  • ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), 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 Busso Hand Volume Severity Scale (BHVSS) 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 BHVSS score. Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows: 4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest; 1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.
Original Primary Outcome Measures  ICMJE
 (submitted: October 28, 2009)
  • To evaluate the safety of Radiesse® Injectable Dermal Filler for hand rejuvenation [ Time Frame: 12 months ]
  • To evaluate the effectiveness of Radiesse® Injectable Dermal Filler for hand rejuvenation using a 4-point ordinal, hand aesthetic rating scale and a 7-point, relative, global aesthetic rating scale [ Time Frame: 12 months ]
  • To evaluate the effectiveness of Radiesse® Injectable Dermal Filler for hand rejuvenation using physician and subject satisfaction questionnaires and a hand function questionnaire [ Time Frame: 12 months ]
Change History Complete list of historical versions of study NCT01004107 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2017)
  • Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand [ 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 Busso Hand Volume Severity Scale (BHVSS) between baseline and 3, 6, 9, and 12 months, by hand, among all treated subjects. Ratings were completed by three, blinded evaluators. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score. Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows: 4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest; 1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.
  • ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Hand [ 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 Busso Hand Volume Severity Scale (BHVSS) between baseline and 3, 6, 9 and 12 months, by hand, among treated subjects. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score. Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows: 4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest; 1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.
  • ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Subject [ 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 Busso Hand Volume Severity Scale (BHVSS) between baseline and 3, 6, 9 and 12 months, by subject, among treated subjects. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score. Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows: 4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest; 1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.
  • Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group and Untreated Controls Only [ Time Frame: 3 months from baseline ]
    To evaluate the efficacy of Radiesse Injectable Dermal Filler for hand treatment as measured by a Global Aesthetic Improvement Scale (GAIS), by hand, as completed by three, blinded evaluators.
  • Global Aesthetic Improvement Scale (GAIS) Ratings of at Least "Improved" Among the Original Treatment Group Only [ Time Frame: 3 months from baseline ]
    Effectiveness was measured by evaluating changes in hand appearance, by subject, using the GAIS completed by three, blinded evaluators
  • Global Aesthetic Improvement Scale (GAIS) Ratings, by Hand [ Time Frame: 3, 6, 9, and 12 months from baseline ]
    To evaluate the efficacy of Radiesse for hand treatment as measured by Global Aesthetic Improvement Scale (GAIS) between baseline and 3, 6, 9, and 12 months, by hand, among all treated subjects. Ratings were completed by three, blinded evaluators.
  • Global Aesthetic Improvement Scale (GAIS) Ratings of at Least "Improved" Over Study [ Time Frame: 3, 6, 9, and 12 months from baseline ]
    Effectiveness was measured by evaluating changes in hand appearance, by subject, between baseline and 3, 6, 9 and 12 months, by subject, among treated subjects using the GAIS completed by three, blinded evaluators
  • Physician Satisfaction Evaluation [ Time Frame: 3, 6, 9, and 12 months from baseline ]
    Effectiveness was measured by evaluating level of satisfaction in subject's hand appearance among physicians between baseline and 3, 6, 9 and 12 months, by subject
  • Patient Satisfaction Evaluation [ Time Frame: 3, 6, 9, and 12 months from baseline ]
    Effectiveness was measured by evaluating level of satisfaction in subject's hand appearance among subjects between baseline and 3, 6, 9 and 12 months
  • Patient Satisfaction Evaluation: Likelihood to Return for Future Radiesse Treatments [ Time Frame: 3, 6, 9, and 12 months from baseline ]
    Effectiveness was measured by evaluating subject's likelihood of return for additional Radiesse hand treatments at 3, 6, 9 and 12 months
  • Mean Hand Function Rating During Prior Week [ Time Frame: Baseline and 3, 6, 9, and 12 months post-treatment ]
    Effectiveness was measured by evaluating subject's hand function during the prior week according to a 5-point Michigan Hand Outcomes Questionnaire (MHOQ) scale at baseline and 3, 6, 9, and 12 months post-baseline, by hand. Questions were as follows and were graded by subject as 1 = very good, 2 = good, 3 = fair, 4 = poor, and 5 = very poor:
    1. Overall, how well did you hand work?
    2. How well did your fingers move?
    3. How well did your wrist move?
    4. How was the strength in your hand?
    5. How was the sensation (feeling) in your hand?
  • Difficulty Performing Activities During Prior Week [ Time Frame: Baseline and 3, 6, 9, and 12 months post-treatment ]
    Effectiveness was measured by evaluating subject's difficulty in performing routine activities during the prior week according to a 5-point Michigan Hand Outcomes Questionnaire (MHOQ) scale at baseline and 3, 6, 9, and 12 months post-baseline, by hand. Activities were as follows and were graded by subject as 1 = not at all difficult, 2 = a little difficult, 3 = somewhat difficult, 4 = moderately difficult, and 5 = very difficult:
    1. Turn a knob
    2. Pick up a coin
    3. Hold a glass of water
    4. Turn a key in a lock
    5. Hold a frying pan
  • Difficulty Performing Activities During Prior Week, Both Hands [ Time Frame: Baseline and 3, 6, 9, and 12 months post-treatment ]
    Effectiveness was measured by evaluating subject's difficulty in performing routine activities, that require both hands, during the prior week according to a 5-point Michigan Hand Outcomes Questionnaire (MHOQ) scale at baseline and 3, 6, 9, and 12 months post-baseline. Activities were as follows and were graded by subject as 1 = not at all difficult, 2 = a little difficult, 3 = somewhat difficult, 4 = moderately difficult, and 5 = very difficult:
    1. Open a jar
    2. Button a shirt / blouse
    3. Eat with a knife and fork
    4. Carry a grocery bag
    5. Wash dishes
    6. Wash your hair
    7. Tie shoelaces / knots
  • Normal Work During Prior Week Evaluation [ Time Frame: Baseline and 3, 6, 9, and 12 months post-treatment ]
    Effectiveness was measured by evaluating subject's ability to work normally, during the prior week according to a 5-point Michigan Hand Outcomes Questionnaire (MHOQ) scale at baseline and 3, 6, 9, and 12 months post-baseline. Activities were as follows and were graded by subject as 1 = always, 2 = often, 3 = sometimes, 4 = rarely, and 5 = never:
    1. How often were you unable to do your work because of problems with your hand(s) / wrist(s)?
    2. How often did you have to shorten your work day because of problems with your hand(s) / wrist(s)?
    3. How often did you have to take it easy at your work because of problems with your hand(s) / wrist(s)?
    4. How often did you accomplish less in your work because of problems with your hand(s) / wrist(s)?
    5. How often did you take longer to do tasks in your work because of problems with your hand(s) / wrist(s)?
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Radiesse® Dermal Filler for Hand Rejuvenation
Official Title  ICMJE Phase 4, Evaluation of Radiesse® Dermal Filler for Hand Rejuvenation
Brief Summary The purpose of this study is to assess the safety and effectiveness of Radiesse® Injectable Dermal Filler for hand treatment.
Detailed Description

This is a prospective, randomized, masked, controlled study to investigate the effectiveness of Radiesse® Dermal Filler for hand treatment.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Aging Hands
Intervention  ICMJE Device: Radiesse Injectable Dermal Filler
Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
Study Arms  ICMJE
  • Experimental: Radiesse Injectable Dermal Filler
    Device: Radiesse Injectable Dermal Filler
    Intervention: Device: Radiesse Injectable Dermal Filler
  • Active Comparator: Delayed Treatment
    Cross over to treatment with Radiesse Injectable Dermal Filler at 3 Months
    Intervention: Device: Radiesse Injectable Dermal Filler
Publications * Busso M,et al. Multi-center Randomized Trial Assessing the Effectiveness and Safety of Calcium Hydroxlapatite For Hand Rejuvenation. Derm Surg 2010; 36:790-797

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2009)
101
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01004107
Other Study ID Numbers  ICMJE P0508332
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merz North America, Inc.
Study Sponsor  ICMJE Merz North America, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Merz North America, Inc.
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP