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Completed

NCT Number: NCT01004107

Evaluation of Radiesse® Dermal Filler for Hand Rejuvenation

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 #001, Munich, Germany

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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.

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 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

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 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.

  2. ≥ 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.

  3. ≥ 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.

Secondary outcomes

  1. 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.

  2. ≥ 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.

  3. ≥ 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.

  4. 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.

  5. 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

  6. 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.

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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:

    • Overall, how well did you hand work?
    • How well did your fingers move?
    • How well did your wrist move?
    • How was the strength in your hand?
    • How was the sensation (feeling) in your hand?

  12. 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:

    • Turn a knob
    • Pick up a coin
    • Hold a glass of water
    • Turn a key in a lock
    • Hold a frying pan

  13. 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:

    • Open a jar
    • Button a shirt / blouse
    • Eat with a knife and fork
    • Carry a grocery bag
    • Wash dishes
    • Wash your hair
    • Tie shoelaces / knots

  14. 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:

    • How often were you unable to do your work because of problems with your hand(s) / wrist(s)?
    • How often did you have to shorten your work day because of problems with your hand(s) / wrist(s)?
    • How often did you have to take it easy at your work because of problems with your hand(s) / wrist(s)?
    • How often did you accomplish less in your work because of problems with your hand(s) / wrist(s)?
    • How often did you take longer to do tasks in your work because of problems with your hand(s) / wrist(s)?

Sponsors and collaborators

Lead sponsor

Merz North America, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 29, 2009
Registry last updated
Jul 13, 2018

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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