Juvéderm

Juvéderm, one of the newest of the so-called “injectable fillers,” is used by cosmetic, dermatological and plastic surgeons to soften deep folds and reduce wrinkles in the faces of patients. The substance is largely comprised of hyaluronic acid, a substance normally found in the skin, muscles, and tendons of mammals. Approved in June 2006 by the U.S. Food and Drug Administration, Juvéderm’s prime use is removing nasolabial folds, or “smile lines,” creases of skin which run from the corners of the nose to the corners of the mouth. It is also used as a lip augmentation agent, and to fill in hollow places and scars on the face. However, all hyaluronic acid facial filler products are eventually absorbed by the body, usually within six to nine months, causing the patient to undergo repeat injections to maintain the younger look. [Monheit, Gary D and Coleman, Kyle M; Dermatologic Therapy 19 (3), 141-150; May 2006.] Juvéderm is also used by physicians to plump up lips which also lose fat and internal shape with normal aging.

FDA testing

Before being released onto the U.S. market, Juvéderm was compared with Zyplast dermal filler, a bovine-based injectable facial filler made from collagen. In clinical studies conducted at several U.S. medical centers to evaluate safety and efficacy, or effectiveness, 146 subjects were followed for 24 weeks. The subjects had Juvéderm injected into one nasolabial fold and Zyplast in the other. Using scientific measuring scales, Juvéderm was deemed to provide a more persistent correction in the subjects’ facial folds. At the end of the study, the researchers asked subjects to judge which fold looked better to them. Eightyeight percent chose the area treated with Juvéderm. [ http://www.dermatologytimes.com/dermatologytimes/article/articleDetail.jsp?id=390574&searchString=Juvéderm] Before FDA approval, two other clinical studies on Juvéderm were done on a total of 293 subjects in the United States. The safety profile and effectiveness was found to be similar to the first test.

History

In 1934, medical researchers Karl Meyer and John Palmer, scientists at Columbia University in New York, found that one of the chief functions of hyaluronic acid is maintaining skin volume and hydration, along with other body maintenance functions and tasks. [McDonald, J and Hascall, V.; J. Biol. Chem., The Discovery of Hyaluronan by Karl Meyer; Vol. 277, No 39, pp 4575-4579; September 2002]

Meyer and Palmer first isolated the substance from the eye of a cow and named hyaluronic acid by combining the Greek word for glass -- hyalos -- and the uronic sugar contained in hyaluronic acid.

Hyaluronic acid later found uses in the baking and food industry in the 1940s and, by the 1990s, found its way into the medical field for use in joint pain, treating wounds, eye surgery and, finally, in 1996, for facial tissue augmentation in Europe.

Current usage

Juvéderm’s current competitive edge in cosmetic surgery is possible because, according to the manufacturers, Juvéderm is “cross linked.” In hyaluronic acid’s natural form, the substance is a liquid which the body metabolizes in about half a day. Cross linking is a process that chemically binds the individual chains of the acid so that it is changed into a gel that lasts much longer once injected inside the face. Several other facial fillers used in Europe and the U.S. -- like Restylane, Belotero and Hylaform -- are also cross-linked, with competition driving the other fillers toward even more highly cross linked compounds, according to Professor Berthold Rzany, professor of dermatology at the Universitaetsmedizon Berlin, Germany.

Mechanism of action

Juvéderm works well for cosmetic and plastic surgery applications because hyaluronic acid can absorb up to 1,000 times its own weight in water, thereby adding new volume under the surface of sagging skin. Older faces take on more youthful aspects because hyaluronic acid is known to bind with collagen -- the material that supports human facial skin -- and elastin to move more basic nutrients into the skin.

When the University of Michigan organized a study on the dermal filler Restylane -- a close chemical sibling of Juvéderm -- researchers found that hyaluronic acid stretches cells in skin known as fibroblasts in a way that causes the skin to create new collagen. The new collagen helps decrease the appearance of facial creases and wrinkles. An unexpected -- and welcome -- finding cropped up: hyaluronic acid also seems to stop the breakdown of existing collagen. [ [http://www.med.umich.edu/opm/newspage/2007/restylane.htm UMHS Press Release: The science behind a wrinkle-filler ] ]

Potential risks and side effects

Patients, physicians and researchers say usual, expected side effects include temporary redness, pain and tenderness during injections and swelling and bruising at the injection sites. The more serious side effects include immune system reactions that result in facial lumps and bumps known as granulomas, bothersome reactions that are very difficult for physicians to treat. [T. Lombardi, J. Samson, F. Plantier, C. Husson, R. Kuffer. Orofacial granulomas after injection of cosmetic fillers. Histopathologic and clinical study of 11 cases. Journal of Oral Path & Medicine, 33 (2), 115-120.] According to Allergan Juvéderm should not be used in patients with severe allergies, particularly those who have allergies to bacterial proteins or patients with a history of anaphylaxis, which is a potentially life threatening hypersensitivity to some drugs and proteins.

References

External links

* [http://www.juvedermusa.com/faq/faq.aspx Juvéderm FAQs]
* [http://www.fda.gov/cdrh/pdf5/p050047b.pdf FDA Summary of Juvéderm’s effectiveness and safety]
* [http://www.fda.gov/cdrh/pdf5/p050047c.pdf FDA: Physician’s instructions (intended use, contraindications, warnings and dosage) for using Juvéderm]