Comparative Study of the Efficacy and Tolerability of a Unique Topical Scar Product vs White Petrolatum Following Shave Biopsies

January 2013 | Volume 12 | Issue 1 | Original Article | 86 | Copyright © January 2013


Leon H. Kircik MD

Mount Sinai Medical Center, New York, NY Indiana University School of Medicine, Indianapolis, IN Physicians Skin Care, PLLC, Louisville, KY

Abstract
An excess of 70 million cutaneous surgical procedures are conducted annually in the United States that may result in scarring. Skin scars are a normal outcome of the tissue repair process. However, individuals with abnormal scarring may have aesthetic, psychological, and social consequences. As a result, there is a high patient demand for products that will reduce the scarring.

The principles underlying scar formation are now better understood. Products are being developed to address those critical components of the wound-healing process, namely inflammation, hydration, and collagen maturation. A multicomponent scar product was previously shown effective in preventing exaggerated scarring in patients undergoing various surgical procedures. The present outpatient study was conducted in patients undergoing shave biopsies. Following reepithelialization, this investigator-blinded, randomized, 8-week trial compared twice-daily application of either the scar product or the standard of care, white petrolatum. Evaluation visits were conducted at baseline and at weeks, 1, 2, 4 and 8. Subjects were evaluated by the blinded investigator for clinical efficacy and tolerability using grading scales. Standardized digital photographs were taken at each visit, and subjects completed a self-assessment questionnaire regarding treatment effectiveness and satisfaction. Twenty-eight subjects completed the 8-week study. The scar product provided earlier improvements than the white petrolatum. At week 1, 70% of subjects receiving the scar product demonstrated at least 50% global improvement in scar appearance vs only 42% of the subjects receiving white petrolatum. The more rapid improvement was accompanied by greater reductions in stinging/burning and itching with the scar product at all visits. Importantly, there was also greater subject satisfaction with the scar product at all visits. This scar product may be useful in hastening the healing of cutaneous shave biopsies and reducing the stinging/burning and itching associated with the normal healing process.

J Drugs Dermatol. 2013;12(1):86-90.

INTRODUCTION

In 1996, cutaneous surgical procedures in the United States were estimated at more than 71 million .1 Each of these cutaneous procedures may result in scarring, which does not include all minor accidents not reported to medical professionals. All wounds heal by scar formation. A “good” scar is one that is flat, thin, flexible, and is similar in color to the surrounding skin rather than one that is hypertrophic, irritable, stretched, and different in color from that of surrounding tissue. Since it is not possible to predict which wounds will proceed to an unsightly scar, patients undergoing a surgical procedure often request a product that will minimize scarring.
Numerous nonprescription products are touted for treatment and prevention of scars. These products contain a wide variety of ingredients, including vitamins, sunscreens, hydroquinone, onion extract, aloe vera, corticosteroids, and silicone. The majority of these products lack data to support their efficacy.2
In 2009, a proprietary combination product was investigated in 120 patients (170 scars) following various surgical procedures to assess its ability to prevent hypertrophic scarring.3 Key ingredients of the combination product include Bulbine frutescens, Centella asiatica, and oleuropein, which were selected to address main areas of scar pathophysiology. These include providing enhanced hydration, controlled inflammation, collagen maturation, and prevention of tension-mediated collagen formation. Assessments were conducted over 6 months using a combination of investigator and patient scar assessment techniques. Treated patients showed improvements in all aspects of assessment.
Shave biopsies are very common outpatient procedures conducted by dermatologists for diagnostic purposes. After cutaneous shave biopsies, the standard-of-care treatment is either topical antibiotic ointments or white petrolatum applied to the wound site with occlusion. Nonetheless, an unsightly scar may result from the procedure, which is often aesthetically unacceptable to patients. The current study was conducted to assess the efficacy and tolerability of a unique combination scar product used following shave biopsies.