ArteFill Skin Test Study
Artes Medical, Inc., a medical aesthetics company, today announced completion of the enrollment and treatment of patients in the ArteFill(R) Skin Test study. The Company reports that 498 study participants are enrolled in the study and have received ArteFill Skin Test injections. The lead investigator in the study is David Wilson, M.D., of The Education and Research Foundation in Lynchburg, VA.
Each participant in the study received the ArteFill Skin Test and was assessed for a positive hypersensitivity reaction to the skin test. Any adverse events were also collected. The primary endpoint of the study is the Investigator’s clinical determination of a positive skin test reaction with histopathology verification. In addition, subjects will have serum antibody levels against bovine collagen evaluated prior to and after treatment in this study.
“We are pleased to announce the completion of enrollment and treatment of patients in this important study,” said Christopher J. Reinhard, Executive Chairman, Artes Medical. “Once all of the data has been fully analyzed, we will determine the appropriate next steps. Positive safety data from this study will be used to support a regulatory submission seeking an amendment to the ArteFill product usage labeling to remove the pre-treatment collagen skin test requirement.”
About ArteFill(R)
ArteFill is the first and only FDA-approved non-resorbable injectable dermal filler for the correction of wrinkles known as smile lines or nasolabial folds. The unique microspheres in ArteFill are not absorbed by the body and therefore provide the first-of-its-kind permanent support for long-lasting wrinkle correction in one to two treatments.
About Artes Medical, Inc.
Artes Medical is a medical aesthetics company focused on developing, manufacturing and commercializing a new category of injectable products for the dermatology and plastic surgery markets. The Company’s flagship product, ArteFill, is being marketed to men and women as a long-lasting treatment option for the correction of nasolabial folds. The Company also markets Elevess(TM), the first FDA-approved hyaluronic acid-based wrinkle filler with lidocaine for patient comfort. Additional information about Artes Medical, ArteFill and Elevess is available at www.artesmedical.com, www.artefill.com and www.myelevess.com respectively.
See Also:
If you enjoyed this post, please consider leaving a comment, subscribe to the feed and get future articles delivered to your feed reader or follow us on Twitter.
There is a new product I came across aimed at sensitive skin. i came across the website (www.riversol.com) and became extremly interested. The doctor is based out in vancouver, and is a celebrity demetoligist. I am very curious to know if there are other places where I can get this product other than online!
Thanks so much