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

Completed · Phase 4

Conditions studied: Nasolabial Folds

In brief

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

Key facts

Study ID

NCT01012388

Run by

Merz North America, Inc.

People needed

100

Starts

2007-03-01

Expected to finish

2008-02-01

Last updated by the study team

2013-04-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Chevy Chase, Maryland, United States
• Study site — Ypsilanti, Michigan, United States
• Study site — New York, New York, United States
• Study site — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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