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Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of Color

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01012388
First Posted: November 13, 2009
Last Update Posted: April 26, 2013
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.
Information provided by (Responsible Party):
Merz Pharmaceuticals, LLC
  Purpose
Post marketing study to assess the likelihood of hypertropic scarring, keloid formation and hyper- or hypopigmentation in patients with Fitzpatrick Skin Types IV, V, and VI receiving nasolabial fold treatment with Radiesse® Injectable Dermal Filler

Condition Intervention Phase
Nasolabial Folds Device: Radiesse® Injectable Dermal Filler Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-Marketing Study of Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of Color

Further study details as provided by Merz Pharmaceuticals, LLC:

Primary Outcome Measures:
  • Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment [ Time Frame: 3 months ]
    Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely

  • Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment [ Time Frame: 6 months ]
    Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely


Enrollment: 100
Study Start Date: March 2007
Study Completion Date: February 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiesse Device: Radiesse® Injectable Dermal Filler
Calcium hydroxylapatite particles suspected in an aqueous based gel carrier

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Is at least 18 years of age.
  • Has Fitzpatrick Skin Type IV, V, or VI.
  • Understands and accepts the obligation not to receive any other procedures or treatments in the nasolabial fold for 6 months.

Exclusion Criteria:

  • Has history of hyper- or hypo-pigmentation in the nasolabial folds, keloid formation, or hypertrophic scarring.
  • Has a known bleeding disorder or is receiving drug therapy that could increase the risk of bleeding.
  • Has nasolabial folds that are too severe to be corrected in one treatment session.
  • Has received any dermal filler or other injections, grafting or surgery in either nasolabial fold.
  • Is pregnant, lactating, or not using acceptable contraception.
  Contacts and Locations
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): NCT01012388


Locations
United States, California
Los Angeles, California, United States
United States, Maryland
Chevy Chase, Maryland, United States
United States, Michigan
Ypsilanti, Michigan, United States
United States, New York
New York, New York, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
Merz Pharmaceuticals, LLC
  More Information

Publications:
Responsible Party: Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT01012388     History of Changes
Other Study ID Numbers: P1206248
First Submitted: November 11, 2009
First Posted: November 13, 2009
Results First Submitted: November 19, 2009
Results First Posted: December 23, 2009
Last Update Posted: April 26, 2013
Last Verified: April 2013

Keywords provided by Merz Pharmaceuticals, LLC:
Moderate to severe wrinkles and folds such as nasolabial folds