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Evaluation of Radiesse® Dermal Filler for Hand Rejuvenation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01004107
Recruitment Status : Completed
First Posted : October 29, 2009
Last Update Posted : June 20, 2014
Information provided by (Responsible Party):
Merz North America, Inc.

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 Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2008
Primary Completion Date : February 2010
Study Completion Date : February 2010

Arm Intervention/treatment
Experimental: Radiesse® Injectable Dermal Filler
Device: Radiesse® Injectable Dermal Filler
Device: Radiesse® Injectable Dermal Filler
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier
No Intervention: Delayed Treatment
Cross over to treatment with Radiesse® Injectable Dermal Filler at 3 Months

Primary Outcome Measures :
  1. To evaluate the safety of Radiesse® Injectable Dermal Filler for hand treatment using a 5-point ordinal rating scale [ Time Frame: 12 months ]

Information from the National Library of Medicine

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

Inclusion Criteria

  • Has right and left hands with a rating of 3 or 4 on the BHVSS as determined by the treating physician
  • Is at least 18 years of age
  • 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 planned activities during study that could interfere with treatment (i.e., boxing) or that impose significant force to the hands.
  • Has history of hypertropic scarring.
  • Has a known bleeding disorder (e.g., thrombocytopenia, thrombasthenia, or von Willebrand's disease).
  • Has received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics , vitamin E or anti-inflammatories within 2 weeks pre treatment.
  • Is receiving systemic corticosteroids or anabolic steroids (standard doses of inhaled or nasal corticosteroids are acceptable).
  • Has a history of chronic or recurrent infection (e.g., Pseudomona paronychia) or inflammation (e.g., rheumatoid arthritis) that would preclude participation in the study.
  • Has a known hypersensitivity to any of the components of Radiesse or local anesthesia.
  • Has received the following in the dorsum of the hand within 4 weeks of treatment or intends to receive these products and or treatments during the study: Over the-counter wrinkle products (e.g., alpha-hydroxy acids) or prescription treatments (e.g., Renova, Retin-A, micro-dermabrasion, chemical peels)
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01004107

Munich, Germany
Sponsors and Collaborators
Merz North America, Inc.

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

Responsible Party: Merz North America, Inc.
ClinicalTrials.gov Identifier: NCT01004107     History of Changes
Other Study ID Numbers: P0508332
First Posted: October 29, 2009    Key Record Dates
Last Update Posted: June 20, 2014
Last Verified: June 2014