Health Promo 03 (Getty) | Advocate.com
||  Health News  ||
 
February 10, 2004

Aventis applies for FDA approval of lipoatrophy treatment

Dermik Laboratories, the U.S. dermatology arm of the Aventis pharmaceutical company, on Monday applied with the Food and Drug Administration for expedited premarket review of its lipoatrophy treatment Sculptra, currently available in Europe, South America, and Australia as New-Fill. The treatment is an injectable synthetic material that can help fill spaces left by the loss of fat under the skin, particularly in the face. New-Fill has been used by an estimated 100,000 people in 30 countries for the treatment of a range of facial problems, including wrinkles, folds, and sunken cheeks.

"Facial lipoatrophy is a condition that results in loss of fat in the cheeks, temples, and eye sockets," says Sharon Levy, senior director of scientific and medical affairs for Dermik Laboratories. "The sunken cheeks, hollow eyes, indentations, and wrinkling may make a person appear exhausted and unhealthy. Lipoatrophy can result from antiretroviral therapy in people with HIV and can have a devastating effect on self-image and confidence. The effects can be so severe that patients may even jeopardize their health by discontinuing their antiretroviral treatment."

The objective of the studies submitted to the FDA was to determine whether Sculptra safely and effectively produced significant improvements in appearance and in restoration of lost facial volume in people with HIV. Researchers also evaluated the quality of life as well as anxiety and depression scores of study participants. The data from these studies show that Sculptra is well-tolerated, with adverse effects generally limited to reactions at the site of the injection, company officials report.

Sculptra, a poly-L-lactic acid (PLLA), is synthetically derived from natural components and is a biocompatible substance that degrades to lactic acid, a substance naturally produced in the muscles of the body. PLLA has been used in surgical products for more than 20 years as a component of dissolvable sutures and is used in several sustained-release injectable medications.

Lipoatrophy, part of an overall condition called lipodystrophy, is a common problem for HIV-positive people taking antiretroviral drugs, particularly protease inhibitors. It is most often marked by subdermal fat loss in the face, arms, buttocks, and legs. Fat deposits also can form on the back and shoulders and in the stomach area as part of lipodystrophy. Elevated cholesterol and triglyceride levels are other common lipodystrophy symptoms.

Reader Comments

These comments are reproduced as written by visitors to this Web site. They have not been edited for content, grammar, or spelling. The viewpoints appearing here are those of the writer, and do not necessarily reflect the opinion or views of advocate.com, The Advocate, or its affiliates.

Be the first to comment on this story.

Back to top

Submit a comment for this story:

*Type your comment here (Required, 1000 characters max.):

*Name (Required): 

*Hometown (Required): 

*E-mail address: (Required, but will not be displayed)

Is this comment for publication? 
Yes   No

Daytime phone number: (Required for print publication only and will not be displayed)

Please enter the words you see in the box, in order and separated by a space. Doing so helps prevent automated programs from abusing this service.

  

If you would like to submit a comment for posting, please fill out the form above. 

All comments submitted via this form are subject to posting or publication. (To send a private letter to an Advocate editor or writer, please use the e-mail button at the top of the page, or use snail mail.) If you would like your comment considered for publication in The Advocate magazine, please include your full name, your city of residence, and a phone number where you can be reached during business hours so that we can confirm your identity. Your e-mail address and telephone number are strictly confidential and will not be shared or used for any purpose other than to contact you about your comment.

See the Contact page for sending comments for reasons other than responding to Advocate editorial and news stories.

Please note that comments sent by fax or snail mail are unlikely to be posted, although they will be considered for publication along with all letters received via e-mail or via this Web page. Comments that chiefly concern Advocate.com content will be considered for posting only on the Web site. The Advocate reserves the right to edit submitted comments for grammar, spelling, obscenities, or libel; we will, however, do our best to preserve the original comment's style and intent. Comments considered for publication in The Advocate magazine may also be edited for length.

More Exclusives
  • Letter From the Editor
    We’d like to unveil a big change: after nearly four decades as a biweekly magazine, we’re going monthly.
  • Parental Control
    San Francisco State researcher Caitlin Ryan explains the importance behind a study linking suicide and drug use among gay children to parental rejection.
  • Austerity Chic
    How novelist and performance artist Mike Albo gets by in lean times.
  • Hoping to "Wu" Michelle
    Dressing Michelle Obama in November was a game changer for designer Jason Wu. Now he has his sights set on the future first lady’s most high-profile event: Inauguration Day.
  • Boi From Troy Signs Off
    After five years of raising eyebrows on the Web, Boi From Troy blogger -- and gay Republican -- Scott Schmidt is signing off.
  • A Desert Journey
    The Mii Amo spa in Sedona, Ariz., is famous for packages designed to lead people through a spiritual as well as physical transformation. One writer relinquishes herself to the journey and recounts her days in one of the world's most beautiful destination resorts.
  • A List: Chris Evans
    Chris Evans is a serious actor but that doesn’t mean he wants you to stop objectifying him.
  • Great American Couple
    In an exclusive excerpt from his new book, Hollywood Bohemians: Transgressive Sexuality and the Selling of the Movieland Dream, Brett L. Abrams explores the relationship between Cary Grant and Randolph Scott, who led homosexual lives right under everyone's nose.
  • Mormons Gone Wild
    After one man undresses missionaries for his calendar, LDS Church–owned Brigham Young University strips him of his degree.
  • Constructive Impatience
    Stung by the Warren decision, GLAAD's former executive director Joan Garry offers the Obama transition team some sage advice.
  • Boxer Goes Trans for Eli Stone
    Often perceived as male by confused casting agents, boxer-body builder turned actor Dallas Malloy felt a deep connection to the trans minister she plays on Eli Stone.
  • Mamma Mia! Rises Again
    Meryl Streep and company managed to top Harry Potter and Titanic at the U.K. box office, and now Mamma Mia! is poised to break similar records on DVD. Director Phyllida Lloyd talked to Advocate.com about bringing one of the biggest musicals of all time to the big screen.
  • The Other White Meat
    As one of the subjects of the documentary about the drag pageant circuit, Pageant, opening in select theaters, and one of the contestants on RuPaul's Drag Race, premiering next month on Logo, Victoria "Porkchop" Parker may not look or act like your typical female impersonator, but make no mistake, she is one of the best.
  • The Religious Defense
    In an excerpt from her new book, Bulletproof Faith: A Spiritual Survival Guide for Gay and Lesbian Christians, author Candace Chellew-Hodge incorporates the wisdom of Xena: Warrior Princess to illustrate her theories as to how gay and lesbian people of faith can protect themselves from those who attack their views.
  • Photo Finish
    Did Prop. 8 backlash cause art censorship -- or its reversal -- at Brigham Young University? Could be, as BYU photography student J. Michael Wiltbank found when his contribution to a two-week-long art exhibition -- eight pairs of benign portraits, each depicting an LGBT-identified BYU student alongside a supportive friend -- had been removed.
  • The Divine Miss M.
    Since the death of performer Wayland Flowers in 1988, his over-the-top puppet creation Madame has been seen only sporadically. But with the launch of her new casino tour, Madame is back.
  • Whither NLGJA?
    The leading professional organization for LGBT journalists is facing a crisis that threatens its very survival. In a changing media landscape and a tough economy, how does a small nonprofit live up to its mission and retain members?
  • The Road to Equality
    Barbara Boxer, the U.S. senator from California, understands why her gay constituents are furious over Rick Warren's role in the inauguration -- it feels like Proposition 8 redux.