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: November 14, 2013
Last verified: November 2013
  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
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: November 14, 2013
Health Authority: Germany: Freiburger Ethik Kommission

ClinicalTrials.gov processed this record on April 17, 2014