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

November 11, 2009
April 19, 2013
March 2007
December 2007   (final data collection date for primary outcome measure)
  • 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
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 by physical exam [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01012388 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of Color
Post-Marketing Study of Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of Color

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

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Nasolabial Folds
Device: Radiesse® Injectable Dermal Filler
Calcium hydroxylapatite particles suspected in an aqueous based gel carrier
Experimental: Radiesse
Intervention: Device: Radiesse® Injectable Dermal Filler
Marmur ES, Taylor SC, Grimes PE, Boyd CM, Porter JP, Yoo JY. Six-month safety results of calcium hydroxylapatite for treatment of nasolabial folds in Fitzpatrick skin types IV to VI. Dermatol Surg. 2009 Oct;35 Suppl 2:1641-5. Epub 2009 Aug 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
February 2008
December 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01012388
P1206248
No
Merz Pharmaceuticals, LLC
Merz Pharmaceuticals, LLC
Not Provided
Not Provided
Merz Pharmaceuticals, LLC
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP