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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT01012388
First received: November 11, 2009
Last updated: April 19, 2013
Last verified: April 2013
History of Changes
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Scars
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: November 11, 2009
Results First Received: November 19, 2009
Last Updated: April 19, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 21, 2013