Post Market Safety Study and Effectiveness With Evolence in Subjects With Skin Color Types IV-VI

Completed · Not applicable

Conditions studied: Non Therapeutic Body Modification

In brief

Approximately 165 subjects with Fitzpatrick Skin Color Types IV, V, and VI and a moderate to deep wrinkle between the corner of the nose and the corner of the mouth, will be treated with EVOLENCE® (an approved collagen filler) to smooth and flatten that wrinkle. They will be observed for 6 months to establish safety of the product as it relates to scarring and changes in skin pigment, and long term effectiveness.

Key facts

Study ID

NCT00891774

Run by

Johnson & Johnson Consumer and Personal Products Worldwide

People needed

172

Starts

2008-12-31

Expected to finish

2009-11-30

Last updated by the study team

2019-02-06

Who can join

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

You may qualify if…

• >18 years of age
• moderate to deep wrinkle in the Naso-Labial fold
• Fitzpatrick Skin Type IV, V or VI

You may not qualify if…

• Pregnant or nursing females
• Hx of allergies to related products
• history of keloids, active skin disease, or previous augmentation of the treatment area

Where it is running

• The Vitiligo and Pigmentation Institute of Southern California — Los Angeles, California, United States
• Desert Dermatology Medical Associates — Rancho Mirage, California, United States
• Center for Dermatology and Dermatologic Surgery — Washington D.C., District of Columbia, United States
• Atlanta Dermatology Vein & Research Center — Alpharetta, Georgia, United States
• Denova Research — Chicago, Illinois, United States
• DuPage Medical Group Clinical Research — Naperville, Illinois, United States
• Callender Center for Clinical Research — Mitchellville, Maryland, United States
• The Boyd Gillard Institute of Aesthetic & Dermatology Surgery — Ypsilanti, Michigan, United States
• Image Dermatology — Montclair, New Jersey, United States
• Susan Taylor — Philadelphia, Pennsylvania, United States
• Tennessee Clinical Research — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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