THE PHYSICIAN’S CHOICE FOR ADVANCED SCAR TREATMENT MAKE EVERY OUTCOME BEAUTIFUL Complete the scar healing process by offering the only Advanced Scar Treatment with FDA-Cleared Silishield™ Technology plus the protection of SPF 30. SILISHIELD™ PATENTED CROSSLINKING SILICONE + SPF 30 by CORNEUM EPIDERMIS DERMIS HOW BIOCORNEUM WORKS Scar Treatment Mechanism of Action 2 1. Healthy skin has a mature stratum corneum that protects the layers below and helps to prevent transepidermal water loss (TEWL). The Science of Scar Reduction BIOCORNEUM’s key ingredient, FDA-Cleared Silishield™ patented crosslinking silicone, advances the benefits of traditional silicone sheeting through the comfort and ease of a gel. Silishield forms a protective shield over the scar area that is optimal for physiological healing and cosmetic improvement. Silishield’s patented technology, made with medical grade silicone, helps to keep skin hydrated and after 2-3 months of use, can normalize excessive collagen formation, that contributes to abnormal scarring1,2. 1 2. A surgical H20 incision or injury creates a gap in the skin’s layers. EPIDERMIS Keratinocytes DERMIS Collagen Fibroblast H20 DERMIS Collagen the reepithelialized area with silicone gel restores the barrier function of the UV stratum corneum, reducing water loss and turning off the stimulation of keratinocytes. BIOCORNEUM’s sunscreen agents protect the scar from the darkening effects of sun exposure. Keratinocytes Collagen Easy, Effective Care for Skin Recovery • FDA-Cleared Silishield™ Technology plus the protection of SPF 30 2 Fibroblast • Silky-smooth clear gel His0simple to apply and is quick-drying 2 H0 H220 • Forms a breathable, flexible protective shield that like a second skin STRATUM moves CORNEUM • Self-adhering – won’t peel, no tape required • Ideal for skin that must flex a lot (such as around joints), irregular surfaces, as well as large scar areas Keratinocytes EPIDERMIS • Ideal for face, neck, chest, hands, and other areas Collagen exposed to the sun DERMIS • Once dry, continues to work when makeup, lotion, or additional SPF protection is applied over it 3. Within one to two weeks, reepithelialization is complete, but the stratum corneum is immature. This allows abnormally high levels of TEWL. Dehydration is signaled (blue arrows) to keratinocytes, setting the scarring process in motion. • Suitable for children over the age of 6 months RESULTS H 0 H20 H20 Silicone gel reduces TEWL2 and normalizes signaling H20 UV UV UV H20 Silicone gel reduces TEWL and normalizes signaling H20 UV 2. Silicone polymers crosslink. H0 H20 Silicone gel reduces TEWL2 and normalizes signaling H20 H20 H20 UV H20 H20 UV 2 3. Volatile silicones evaporate. 5 H20 H20 BIOCORNEUM should be used UV twice a day for two to three months. 3 4. Polysiloxanes and Silicon Dioxide remain adhered to skin, creating the silicone sheet barrier. 6 H20 4 5. SPF 30 ingredients help provide protection from discoloration caused by the sun. H20 UV After - 3 months UV 1 The International Clinical Recommendations on Scar Management named silicone as the single most recommended topical (non-invasive) treatment for scars3. Before BIOCORNEUM applied to the skin. UV 6. For maximum H20 Silicone gel reduces TEWL and normalizes signaling H20 H20 H20 effectiveness, 3 Fibroblast H20 Fibroblast H20 of 1.reduces Thin TEWL layer H20 Silicone gel and normalizes signaling H20 4 H0 5. Treatment of H 0 H220 H20 Silicone gel reduces TEWL2 and normalizes signaling H20 UV EPIDERMIS Silishield™ Mechanism of Action H0 H20 H220 Fibroblast STRATUM CORNEUM STRATUM DERMIS STRATUM CORNEUM H0 H220 CORNEUM Sunscreen agents protect the area from sun exposure’s darkening effects while BIOCORNEUM maintains its silky-smooth feel and clear appearance. It is peace of mind protection that goes everywhere EPIDERMIS the day demands.Keratinocytes 0 4. ExcessHcollagen 2 production leads to abnormal scarring. This results from keratinocytes producing cytokines (red arrows), which in turn activate Keratinocytes dermal fibroblasts that then synthesize Collagen and release collagen. H20 STRATUM CORNEUM DERMIS Collagen Fibroblast H20 EPIDERMIS Keratinocytes Before After - 3 months Before After - 3 months 5 H20 AVAILABLE EXCLUSIVELY FROM PHYSICIANS BIOCORNEUM. Every Scar. Every Day. 39% to 68% of patients develop hypertrophic scars after surgery 4. BIOCORNEUM gives patients control toward a beautiful recovery. BIOCORNEUM by Sientra is the only advanced scar treatment with FDA-Cleared Silishield™ patented crosslinking medical grade silicone plus the protection of SPF 30 — to support healing skin inside and out. BIOCORNEUM forms an invisible shield to create an optimal healing environment that can: • prevent and minimize the formation of hypertrophic and keloid scars, • decrease the appearance of old scars, and • help to restore the function of affected skin. For maximum effectiveness, BIOCORNEUM should have 24-hour contact with the scar area for the duration of the treatment. This can be achieved by applying BIOCORNEUM twice a day. Recommended minimum treatment time: Recommended sizing: Length of scar based on a linear scar with a coverage width of 0.5 inch, at two applications per day. 2-3 INCHES 10g new scars: 60 DAYS 4-6 INCHES 20g older scars: 90 DAYS 7-9 INCHES 50g How to apply BIOCORNEUM • Ensure that the affected area is clean and dry. • Apply a thin, even layer two times a day (morning and evening) over the scar area. • Allow to dry completely. • After application wait 15 minutes before sun exposure. 1. Suetake T, Sasai S, Zhen YX, Tagami H. Effects of silicone gel sheet on the stratum corneum hydration. Br J Plast Surg. 2000;53:503–507. 2. Mustoe TA. Evolution of silicone therapy and mechanism of action in scar management. Aesth Plast Surg. 2008;32:82-92. 3. Gold MH, McGuire M, Mustoe TA et al. Updated international clinical recommendations on scar management: Part 2 - algorithms for scar prevention and treatment. Dermatol Surg. 2014;40:825-831. 4. Chernoff WG, Cramer H, Su-Huang S. The efficacy of topical silicone gel elastomers in the treatment of hypertrophic scars, keloid scars, and post-laser exfoliation erythema. Aesth Plast Surg. 2007;31(15):495-500. MDC-0200 R1 • Once dry, BIOCORNEUM can be covered with pressure garments, clothing, cosmetics or additional sunscreen as needed. • If the affected area is subject to abrasion, it may be beneficial to repeat the application. Important: BIOCORNEUM is for external use only. Avoid direct contact with eyes, mucous membranes, third degree burns, and open wounds. BIOCORNEUM should not be used on damaged or broken skin. This product has not been shown to help prevent skin cancer or early skin aging. Manufactured in the USA for Sientra, Inc., Santa Barbara CA 93117 Silishield™ is a trademark of Sientra, Inc. US Patents: #5,741,509, #8,021,683, #8,263,114 © 2017 Sientra, Inc. All rights reserved. sientra.com • 888.708.0808
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