Clinical Studies

Clinical Trials: Abstract release – September 22, 2005

Silicone Base Product versus Talsyn-CI/Bid
A Comparative Analysis- Cohort Study

Robert J. Mirabile, M.D. FACPRS
Richard M. Goldfarb, M.D., FACS
David J. Miller D.O. FAAFP

BACKGROUND: After review of the 4 billion dollar scar cream market, it was found that there has not been a totally effective treatment for keloids or erythema, or a product that is capable of improving tensile strength and the appearance of scars.  Scars, which are made up of fibrous connective tissue, have not been adequately improved by the use of currently available products to meet both physician and patient standards.  The aim of our study was to clinically prove that treatment with Talsyn-CI/bid exceeds the silicone base products that are currently being sold as an effective treatment for scars.

STUDY DESIGN:  20 patients from the practice of Robert J. Mirabile, M.D. were studied.  This group consisted of 3 men and 17 women undergoing various plastic surgery procedures.  All patients were instructed to apply the silicone base product and Talsyn-CI/bid on a particular portion of the surgical scar and/or a particular scar if bilateral incisions were made.   Patients were evaluated in the three categories of redness, thickness and patient preference. Each category was recorded at weeks ranging from 2-12.  Results for redness and thickness were recorded on a scale of 0-10 with a 10 as the worst and 0 as the best improvement.  The redness was visually inspected with photographic documentation.  The thickness was graded with a micrometer when applicable.  At the conclusion of the study, patients designated their preferential choice.

RESULTS:  16 of the 20 patients completed the 12-week study. Results were tabulated and photographed at each patient visit.  From weeks 2 to 12 the patient and Dr. Mirabile noted a significant cosmetic result.  A progressive improvement and cosmetic difference became more apparent as time passed from the initial surgery.  Of the 16 patients, 15 patients preferred the use of Talsyn-CI/bid due to the cosmetic result, the ease of application, pleasant aroma, non-irritation of the scar, non-stain of clothing, 2/day application (bid), ability to wear makeup over the Talsyn-CI/bid and the ability to apply Talsyn-CI/bid to fresh incisions. There were no adverse reactions.

CONCLUSIONS:  Based on the above objective and subjective findings contained in this study, Talsyn-CI/bid has been shown to be statistically significant and far superior when compared to silicone base products for enhancing the aesthetic appearance of scars, as well as improving the skin elasticity and stimulation of collagen synthesis. This physician-only patent pending scar product has been proven to be the physician and patient product selected in the treatment of scars. The significant improvement documented in this study warrants the use of Talsyn-CI/bid as the first line choice on all surgical incisions to aid in the reduction of scar formation.

Received  August 30, 2005 ; Accepted  September 14, 2005

Robert J. Mirabile, M.D. FACPRS  is certified by the American Board of Plastic Surgery and is a member of the American Society for Aesthetic Plastic Surgery. He is a Fellow of the  American   College  of Surgeons. In 1981, Dr. Mirabile received his medical degree from  Jefferson   Medical   College . After completing a full residency in general surgery at  Jefferson , Dr. Mirabile was accepted into the plastic surgery program at the  University  of  Pennsylvania , which he completed in 1989.   Dr. Mirabile practices plastic and reconstructive surgery in Philadelphia  and  Montgomery   County  areas.

Richard M. Goldfarb, M.D. FACSis certified by the American Board of Surgery.   He is a Fellow of the American   College  of Surgeons.   In 1983, Dr. Goldfarb received his medical degree from the University  of  Health Sciences/Chicago Medical School .   He completed his surgical residency at Northeastern Ohio College of Medicine. Dr. Goldfarb began his general surgery practice in 1989 and is the Medical Director of Bucks County Clinical Research facility in Morrisville ,  Pennsylvania .   President and CEO of MedElite, Inc., wholly owned subsidiary of Nuvilex, Inc.

David J. Miller, D.O. FAAFP is a Fellow of the  American   Academy of Family Practice.   He is board certified by the American Board of Family Practice since 1979 and was re-certified in 1994.   Dr. Miller received his medical degree from Philadelphia College of Osteopathic Medicine and completed his internship at Chicago   Osteopathic   Hospital . Dr. Miller has been the Director of Pennsbury Family Medical Center since 1974 and Director of Bucks County Clinic Research since 1988. He has completed over 270 clinical studies for every major pharmaceutical company worldwide.

Clinical Trials:  Talsyn-CI/bid has been clinically proven to aid the physician with the management of scars.  Talsyn-CI/bid continues to be clinically studied through an FDA approved clinical research facility with a history of over 270 completed clinical studies in their 27th year of operation.

To obtain a copy of the clinical study or for more information contact Talsyn Corporation