Evaluation of Radiesse® Dermal Filler for Hand Rejuvenation
This study has been completed.
Sponsor:
Merz Pharmaceuticals, LLC
Information provided by (Responsible Party):
Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT01004107
First received: October 27, 2009
Last updated: April 19, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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
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: | April 19, 2013 |
| Health Authority: | Germany: Freiburger Ethik Kommission |
ClinicalTrials.gov processed this record on June 17, 2013