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

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.