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

Merz North America, Inc.100 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Nasolabial Folds

Interventions

Radiesse® Injectable Dermal FillerDEVICE

Calcium hydroxylapatite particles suspected in an aqueous based gel carrier

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (5)

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Chevy Chase, Maryland, United States

Unnamed facility

Ypsilanti, Michigan, United States

Unnamed facility

New York, New York, United States

Unnamed facility

Outcomes

Primary Outcomes

Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment

Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely

Time frame: 3 months

Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment

Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely

Time frame: 6 months

Data from ClinicalTrials.gov

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