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Evaluation of Radiesse® Dermal Filler for Hand Rejuvenation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT01004107
First received: October 27, 2009
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Aging Hands
Device: Radiesse® Injectable Dermal Filler
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Merz Pharmaceuticals, LLC:

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

Enrollment: 101
Study Start Date: September 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01004107

Locations
Germany
Munich, Germany
Sponsors and Collaborators
Merz Pharmaceuticals, LLC
  More Information

No publications provided

Responsible Party: Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT01004107     History of Changes
Other Study ID Numbers: P0508332
Study First Received: October 27, 2009
Last Updated: June 17, 2014
Health Authority: Germany: Freiburger Ethik Kommission

ClinicalTrials.gov processed this record on November 25, 2014