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

NCT00891774

CompletedNA

Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide

Conditions: Non Therapeutic Body Modification

Interventions: EVOLENCE®

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

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

Exclusion Criteria:

* Pregnant or nursing females
* Hx of allergies to related products
* history of keloids, active skin disease, or previous augmentation of the treatment area
Locations (11)
  • Los Angeles, California, United States
  • Rancho Mirage, California, United States
  • Washington D.C., District of Columbia, United States
  • Alpharetta, Georgia, United States
  • Chicago, Illinois, United States
  • Naperville, Illinois, United States
  • Mitchellville, Maryland, United States
  • Ypsilanti, Michigan, United States
  • Montclair, New Jersey, United States
  • Philadelphia, Pennsylvania, United States
  • Nashville, Tennessee, United States