Conducting Clinical Trials of Non-Surgical Treatment of Cellulite

Submitted by Stony Brook Surgery on Tue, 04/23/2013 - 07:28

<P class=subhead>Drug Developed by Stony Brook Researchers Shows Potential as Therapy</P>

<DIV class=photobox2>
<img src="/sdmpubfiles/dagum-badalamente.jpg" width="180" height="220" alt="Drs. Alexander B. Dagum and Marie A. Badalamente" title="Drs. Alexander B. Dagum and Marie A. Badalamente" />
<br />
<div class="caption">Drs. Alexander B. Dagum and<br />
Marie A. Badalamente</div></DIV>

<P>No effective treatment currently exists for cellulite; that is, the condition associated with the dimpled appearance of skin, commonly on the
thighs and buttocks. According to the American Society for Aesthetic Plastic Surgery, up to 90% of women and 10% of men have cellulite.</P>

<P>An effective, long-lasting treatment remains the goal of both researchers and countless patients.</P>

<P><a href="/surgery/people/faculty/dr-alexander-b-dagum">Alexander B. Dagum, MD</a>, professor and interim chairman of surgery, and also
chief of plastic and reconstructive surgery, and Marie A. Badalamente, PhD, professor of orthopaedics, have collaborated on the development of
a collagenase (enzyme) injection method specifically for treating cellulite.</P>

<P>This collagenase injection would break down the collagen that anchors fat tissue beneath the skin and, thereby, even out skin irregularities
caused by cellulite. Drs. Dagum and Badalamente hope their research will result in the first effective treatment of cellulite.</P>

<P>At present, a phase 2 clinical trial of the collagenase treatment is planned to start in the fall of 2013. It will follow the successful phase 1 pilot
study that yielded promising results.</P>

<P>"While cellulite isn’t harmful, it is a serious cosmetic concern for many people who want to feel better about their appearance and reduce
cellulite as much as possible," says Dr. Dagum. "The methods to remove cellulite are many, but none yet have been supported in medical
literature to be effective or potentially usable as a standard practice."</P>

<DIV class="callout"><P><STRONG>The pilot study of the new drug found that, after six months, patients had on average a<br />
76% reduction of cellulite in the treated area, which is a promising demonstration of effectiveness.</STRONG></P></DIV>

<P>"We are looking for a standard and safe method of treating cellulite, one that can be effective for a long period of time," says Dr.
Badalamente. She explains that current approaches to reduce cellulite, such as laser therapy, massage treatments, or topical creams show little
evidence of significantly reducing cellulite.</P>

<P>In 2006, Drs. Badalamente and Dagum obtained an investigational new drug number from the U.S. Food and Drug Administration (FDA) for
collagenase in the treatment of cellulite.</P>

<P>They completed their pilot study in which 10 women were treated with the collagenase treatment here at Stony Brook. The study was
presented at the 2006 American Society of Plastic Surgeons’ Annual Meeting held in San Francisco, CA.</P>

<P>Participants in this trial had a collagenase injection based on the assessment of cellulite on the back of their thighs. The area of cellulite was
quantified in centimeters with photo documentation. On average, a 77% reduction of cellulite occurred one day after the injection.</P>

<P>After six months, patients had on average a 76% reduction of cellulite in the injected area. Only minimal side effects occurred, such as
black-and-blue areas, soreness, and mild edema, shortly after the injection. After six months, the patients reported an average satisfaction score
of 1.75 (1 = completely satisfied, 4 = not satisfied).</P>

<P>"To have a significant reduction of cellulite after six months from an injection that is shown to be safe is promising for patients and warrants
continued testing within the FDA regulatory process," says Dr. Badalamente, summarizing the pilot study.</P>

<P>She emphasizes the overall study results were proof of concept for collagenase efficacy and safety in treating cellulite.</P>

<DIV class="subhead">Expanding Drug’s Indications</DIV>

<P>
<DIV class=photobox2>
<a href="http://medicine.stonybrookmedicine.edu/sdmpubfiles/CCH%20before%20and%2…; title="Before and After Collagenase Treatment of Cellulite" class="colorbox colorbox-insert-image" rel="gallery-all"><img typeof="foaf:Image" src="http://medicine.stonybrookmedicine.edu/sdmpubfiles/styles/240/public/CC…; alt="Before and After Collagenase Treatment of Cellulite" title="Before and After Collagenase Treatment of Cellulite" class="image-240" /></a>
<br />
<div class="caption">Patient's upper thigh before collagenase treat-<br />
ment and at six months after treatment, showing<br />
reduced cellulite (click on image to enlarge).</div></DIV>

The collagenase drug, under the trade name <a href="http://stonybrookmedicine.edu/newsroom/dups&quot; target="_blank">Xiaflex</a>, is currently marketed and distributed by
Auxilium Pharmaceuticals, which has been licensed to sell the drug for the treatment of Dupuytren’s contracture, a debilitating hand disorder.</P>

<P>The results of the pilot study for cellulite and additional evaluation of collagenase by Auxilium prompted the company to expand the field of its
license for the drug in January 2013 to include the potential treatment of adults with cellulite.</P>

<P>Auxilium is responsible for the research, development, and new potential use of the drug for the treatment of cellulite. This includes clinical
trials. Should the drug be FDA-approved for this new indication, the company will also be responsible for its marketing and distribution.</P>

<P>In February 2010, the FDA approved the drug as the first non-surgical treatment of Dupuytren’s contracture, which is caused by progressive
accumulation of collagen that deforms fingers and limits motion of the hand. </P>

<P>The drug was originally developed for the use in Dupuytren’s contracture by Dr. Badalamente and her colleague Lawrence C. Hurst, MD,
professor and chairman of orthopaedics, and their research has been reported in several journals, including the <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa0810866&quot; target="_blank"><em>New England Journal of Medicine</em></a>. </P>

<P>Cellulite is formed of normal fat, anchored by collagen strands, beneath the skin. The irregular anchoring of this fat creates the dimpled
appearance of the skin. There is no clear cause of cellulite, though factors may include genetics, hormone changes, lack of physical activity, slow
metabolism, and poor diet.</P>

<P><span class="pointer"><STRONG>Phase 2a placebo-controlled clinical trials using the experimental drug treatment of cellulite are projected to start at Stony Brook Medicine in the second half of 2013. For more information, please call Dr. Dagum's office at 631-444-9265.</strong></span></p>