Featured Research

from universities, journals, and other organizations

Clinical trials for cellulite treatment on the horizon

Date:
April 16, 2013
Source:
Stony Brook Medicine
Summary:
Projected to start in the second half of 2013, researchers plan to begin phase IIa placebo-controlled clinical trials using a drug treatment method developed here to treat cellulite. The treatment method uses clostridial collagenase histolyticum (“CCH”), an injectable form of the enzyme collagenase.

Projected to start in the second half of 2013, researchers at Stony Brook University plan to begin phase IIa placebo-controlled clinical trials using a drug treatment method developed here to treat cellulite. The treatment method is licensed to BioSpecifics Technologies Corp. ("BSTC"), sublicensed to Auxilium Pharmaceuticals, Inc., ("Auxilium"), and uses clostridial collagenase histolyticum ("CCH"), an injectable form of the enzyme collagenase.

Related Articles


To date, there has been no Food and Drug Administration (FDA) approved treatment for cellulite, which is the normal fat beneath the skin that pushes against connective tissue (collagen) anchoring strands, causing a dimpled effect on the skin above it. According to the American Society for Aesthetic Plastic Surgery, up to 90 percent of women and 10 percent of men -- millions of people worldwide -- have cellulite.

Marie A. Badalamente, PhD, Professor Orthopaedics, and Alexander B. Dagum, MD, Professor of Surgery and Orthopaedics, Interim Chair of Surgery and Chief of Plastic and Reconstructive Surgery at Stony Brook University School of Medicine, are planning to be investigators in the pending trials. Their collaboration has led to the development of a collagenase injection method aimed at treating cellulite. The injection is designed to break down collagen that anchors cellulite dimples and, consequently, even out skin irregularities caused by the cellulite. They hope that their bench-to-bedside research will result in the first medically based effective and FDA approved treatment.

"We are looking for a standard and safe method of treating cellulite and one that can be effective for a long period of time," said Dr.Badalamente, who explained that current approaches, such as laser therapy, massage treatments or topical creams show limited evidence of significantly reducing cellulite.

"While cellulite isn't harmful, it is a serious cosmetic concern for many people who want to feel better about their appearance and who want to reduce cellulite as much as possible," said Dr. Dagum. "There are many methods to remove cellulite but few have been supported in medical literature to be effective or potentially usable as a standard practice."

In 2006 the researchers obtained an investigational new drug number from the FDA for CCH in the treatment of cellulite. They subsequently completed a phase I pilot clinical trial of 10 women treated at Stony Brook for cellulite.

Participants received CCH injections based on an assessment of cellulite on the back of their thighs. The area of cellulite was quantified in centimeters with photo documentation. On average, there was a 77 percent reduction of cellulite as soon as one day after the injection. After six months, the patients had on average a 76 percent reduction of cellulite in the injected area. Only minimal side effects were reported, such as, bruising, 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).

"We believe that a significant reduction of cellulite after six months from an injection that appears to be well-tolerated is promising for patients and warrants continued testing within the FDA regulatory process," said Dr. Badalamente, summarizing their pilot study. She emphasized the overall study results were indicators of potential proof of concept for CCH efficacy and safety in treating cellulite.

The results of the study and additional evaluation of CCH by Auxilium prompted the company to expand the field of its license for CCH in January 2013 to include the potential treatment of adults with cellulite. Auxilium is currently licensed to market and distribute XIAFLEX® (an FDA-approved version of CCH) to treat adult Dupuytren's contracture patients with a palpable cord, a debilitating hand disorder and is under FDA review for the potential treatment of Peyronie's disease.

Auxilium is responsible for the research, development and potential use of CCH for the treatment of cellulite. This includes the development of clinical trials. Should a formulation of CCH receive FDA approval for this new indication, Auxilium will also be responsible for the commercialization, marketing, sales and distribution of CCH for the treatment of cellulite.


Story Source:

The above story is based on materials provided by Stony Brook Medicine. Note: Materials may be edited for content and length.


Cite This Page:

Stony Brook Medicine. "Clinical trials for cellulite treatment on the horizon." ScienceDaily. ScienceDaily, 16 April 2013. <www.sciencedaily.com/releases/2013/04/130416144618.htm>.
Stony Brook Medicine. (2013, April 16). Clinical trials for cellulite treatment on the horizon. ScienceDaily. Retrieved December 19, 2014 from www.sciencedaily.com/releases/2013/04/130416144618.htm
Stony Brook Medicine. "Clinical trials for cellulite treatment on the horizon." ScienceDaily. www.sciencedaily.com/releases/2013/04/130416144618.htm (accessed December 19, 2014).

Share This


More From ScienceDaily



More Health & Medicine News

Friday, December 19, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

The Best Tips to Curb Holiday Carbs

The Best Tips to Curb Holiday Carbs

Buzz60 (Dec. 19, 2014) — It's hard to resist those delicious but fattening carbs we all crave during the winter months, but there are some ways to stay satisfied without consuming the extra calories. Vanessa Freeman (@VanessaFreeTV) has the details. Video provided by Buzz60
Powered by NewsLook.com
Sierra Leone Bikers Spread the Message to Fight Ebola

Sierra Leone Bikers Spread the Message to Fight Ebola

AFP (Dec. 19, 2014) — More than 100 motorcyclists hit the road to spread awareness messages about Ebola. Nearly 7,000 people have now died from the virus, almost all of them in west Africa, according to the World Health Organization. Video provided by AFP
Powered by NewsLook.com
Researchers Test Colombian Village With High Alzheimer's Rates

Researchers Test Colombian Village With High Alzheimer's Rates

AFP (Dec. 19, 2014) — In Yarumal, a village in N. Colombia, Alzheimer's has ravaged a disproportionately large number of families. A genetic "curse" that may pave the way for research on how to treat the disease that claims a new victim every four seconds. Duration: 02:42 Video provided by AFP
Powered by NewsLook.com
Double-Amputee Becomes First To Move Two Prosthetic Arms With His Mind

Double-Amputee Becomes First To Move Two Prosthetic Arms With His Mind

Buzz60 (Dec. 19, 2014) — A double-amputee makes history by becoming the first person to wear and operate two prosthetic arms using only his mind. Jen Markham has the story. Video provided by Buzz60
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
 
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:  

Breaking News:

Strange & Offbeat Stories

 

Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:  

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile iPhone Android Web
Follow Facebook Twitter Google+
Subscribe RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins