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A Post Approval, Mulitcenter, Open-Label, Longitudinal, Uncontrolled Safety Study of Cosmetic Tissue Augmentation Product (ELEVESSTM) in the Treatment of Nasolabial Folds in People of Color (Protocol# CTA0701)

Principal Investigator:   Andrew Alexis, MD
Co-investigators:   Marcelyn Coley, MD
Time frame of study:   June 2009-February 2010
Time frame of participation:   Approximately 6 months
Number of participants needed:   10
Location of Study:  

St. Luke’s Hospital
1090 Amsterdam Avenue
Suite 11D
New York, NY 10025
Contact Number:   Clinical Research office
(212) 523-4511


Summary:
This is an open-label, longitudinal, uncontrolled study to evaluate the safety of an FDA-approved injectable device, including the likelihood of keloid formation and pigmentation changes and other potential adverse events in people of color (Fitzpatrick skin types IV, V and VI) who have elected to undergo nasolabial fold treatment with intradermal (deep dermal) injection of cosmetic tissue augmentation (CTA). Subjects will be followed for a minimum of 24 weeks with visit assessments at 2, 6, 12 and 24 weeks after the last injection.

Criteria for Participation:

  • 18 years or older
  • Desires correction of deep nasolabial folds (smile lines)
  • Patients of color (Fitzpatrick skin types IV-VI)
  • No prior dermal filler injetions in the face
  • No facial aesthetic procedures in past 6 months
  • No skin disease (e.g. acne, acne scarring, pigmentation disorders) near site of injecti

Benefits:

  • Evaluation and treatment by a board certified dermatologist
  • Correction of deep nasolabial folds with an FDA approved cosmetic tissue augmentation device at no cost to subject