StrataXRT. for the management of radiation induced skin reactions

StrataXRT for the management of radiation induced skin reactions

Radiation Dermatitis The Unwelcome Consequence of a Life-Saving Therapy Radiation dermatitis is an acute skin reaction affecting approximately 95% of patients who receive radiation therapy to the breast, groins or perineum. 1,2,3 It generally ranges from erythema to dry or even moist desquamation and can be a source of significant pain, discomfort and psychological distress. In particular, moist desquamation poses the risk of infection and can result in treatment breaks which impair patient outcomes. 3 Up to 50 60% of patients receiving cancer treatment will undergo radiation therapy at some stage of their illness. 1,4,5 The introduction of modern mega-voltage treatment machines with skin-sparing capabilities have improved but not eliminated skin toxicities. 6 How do the current therapies rate? Studies assessing lotions, creams, or emulsions (aloe vera, hyaluronic acid, corticosteroids, sucralfate) either showed no benefit in managing radiation dermatitis or provided conflicting evidence. 7,8,9 It is essential that any skin damage is minimized by ensuring that interventions are based upon best practice, and supported by evidence-based guidelines. 2 Consensus goals of care for skin reactions during radiation therapy 8, 10, 11 StrataXRT scores Initial maintenance of skin integrity Reduced potential of further exacerbation of skin reactions Minimized water loss and optimized skin hydration by means of topical agents Promotion of comfort and compliance Reduction of pain and pruritus without causing a bolus effect Control of bleeding, odor and excessive exudate (in combination with secondary dressing) Provides ideal environment for rapid healing and re-epithelialization Promotion of moist wound healing environment where skin is broken Protection from trauma & friction Protection of infection 2 Web www.civcort.com Email info@civcort.com

The RTOG Scale for Radiation Dermatitis The RTOG scale (Radiation Therapy Oncology Group) provides a standardized description of radiation induced side effects. Interventions are usually matched to the skin s reaction based on its assessment and the RTOG score. RTOG Scale Score Observation: External Signs Observation: Cellular Level Clinical Assessment Treatment Goals 0 No visible change to skin Maintain soft, supple, clean, odor free and intact skin. 1 Redness. Inflammation Mild tightness/itch Maintain soft, supple, clean odor free, intact skin, reduce irritation and promote comfort. 2 Sensitive skin with bright redness With/without dry desquamation Tightness/itch/sore Promote skin hydration, comfort and maintain skin integrity. Reduce itch, pain, soreness and discomfort. 2.5 3 Patchy moist desquamation Moderate oozing Confluent moist desquamation Pitting oozing 4 Ulceration, bleeding, necrosis Reduce risk of complications of further trauma and infection. Reduce pain, soreness and discomfort. 13 Reduce the risk of infection, minimize pain and trauma of the skin. Debride the wound. Control associated blee ding and oozing (exudate), minimize effects of wound infection. Photos from several patients. Other scales of measurement include RISRAS and CTCAE. The key measurement point on this RTOG scale is level 2.5 (2b), which denotes the first level of the appearance of moist desqumation. Images (RTOG 0 3) courtesy of The Princess Royal Radiotherapy Review Team, St James s Institute of Oncology, The Leeds Teaching Hospitals NHS Trust. Taken from the publication Managing Radiotherapy Induced Skin Reactions, a Toolkit for Healthcare Professionals. Progression of symptoms and skin changes according to the RTOG scale during radiation therapy* * Curve generated from the general progression of radiation dermatitis for patients undergoing radiation therapy. Levels of reaction differ significantly between patients and treatments. If untreated however the level of reaction generally follow the shape of this curve. 4 Global Sales 800.842.8688 +1 712.737.8688 3

Why is StrataXRT an Innovative Wound Dressing? StrataXRT film-forming gel dries as a thin, flexible and protective layer that is gas permeable, waterproof, inert and has no measurable ph value. Can be applied from day one of radiation therapy Faster re-epitheliali zation12 promoted by a moist wound healing environment Does not cause bolus effect14 Lightly bonds to the most superficial damaged layer of the skin Sterile, biologically inert and bacteriostatic Fast drying For best resut, leave in constant contact with the skin Full contact flexible wound dressing Management of Radiation Dermatitis with StrataXRT Application of StrataXRT Stratum corneum Immature cell Dead cell StrataXRT helps to reduce Trans Epidermal Water Loss (TEWL) while promoting a moist wound healing environment, leading to: Faster re-epithelialization12 of the skin posttherapy Relief of low grade cutaneous changes such as dry, itching, flaking, peeling and irritated skin Reduced pain, redness and heat, while helping to soothe exposed areas in more severe inflammatory changes StrataXRT protects the fragile epidermis during dry desquamation leading to: Preservation of the skin integrity Prevention of excessive sloughing of the outmost layers Irradiated site StrataXRT protects the dermal stroma from long-term deterioration during moist desquamation leading to: O ptimization of the environment for the reparative process Reducing the risk of infection 4 Web www.civcort.com Email info@civcort.com

Clinical Study A 28-patient multicenter study performed in Spain (2015). Starting of ther apy: RTOG score of 2.5 ± 0. 5. All patients were treated with StrataXRT while undergoing radiation therapy. 13 S trataxrt reduces the severity of radiation induced skin reactions and significantly decreases the RISRAS score, even if patients are undergoing radiation therapy treatment. Measurement of Clinical Signs and Symptoms During Radiation Therapy Treatment Evaluation scale 4.0 3.5 3.0 2.5 2.0 1.5 1.0 0.5 0.0 Day 1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 70 60 50 40 30 20 10 0 Number of Grays Cumulative radiation dose First day of radiation therapy Application of StrataXRT Pain Itching Burning sensation Erythema Hydration During the application period, StrataXRT showed a decrease of pain by 20.48%*, of the itching by 22.22%*, of the burning sensation by 24.69%*, the erythema by 21.13%* and an improvement of the hydration by 26%*. (*p-value <0.05) Evolution of Risras Score During Radiation Therapy Treatment and When Applying StrataXRT Evaluation scale REDUCTION OF 16.85% 16.1 16.0 15.0 14.0 13.4 13.0 12.0 Day 30 31 32 33 34 35 36 37 38 39 40 60 55 50 45 40 Number of Grays Cumulative radiation dose RISRAS score (Radiation-induced Skin Reactions Assessment Scale) StrataXRT Does Not Cause Bolus Effect The Springfield Radiation Oncology Center in Australia conducted measurements on increasing electron beam energy levels to verify the bolus effect of a clinical dose of StrataXRT. 14 This study showed that StrataXRT does not cause a bolus effect since the energy of the beam is not affected by the product. Method Figure 1 shows the experimental setup of the dosimetric measurement. Three readings were made for each of the energy levels (6, 9, 12, 16 MeV). The first time without the application of StrataXRT, the second time with the application of StrataXRT. Figure 1 SSD 100cm 10 10cm Field Size Electron Beam (6/9/12/16 MeV) StrataXRT Solid Water Roos Chamber Measurements at Different Energy Levels with and without StrataXRT Application Nanocloulombs 14 12 10 8 6 4 2 0 0% 6 MeV 0% -0.1% -0.1% 9 MeV 12 MeV 16 MeV with StrataXRT without StrataXRT Global Sales 800.842.8688 +1 712.737.8688 5

Radiation Dermatitis Case Studies: All patients continued radiation therapy while applying StrataXRT Case Study Korea, 2015 Yonsei University Health System, Severance Hospital, Korea A series of case studies was performed for treatment of radiation dermatitis at different RTOG stages of toxicity. Patients and nurses reported an overall improvement, reduced itching and pain symptoms. Patients positively evaluated the transparency of StrataXRT once it dried, while protecting the affected area. 15 Head and Neck Cancer Patient showing a RTOG 3 radiation dermatitis with moderate edema and a confluent moist desquamation. Patient applied StrataXRT during ongoing radiation therapy. After 7 days of topical treatment, the moist desquamation and edema resolved and the skin pigmentation improved. Patient showing a severe RTOG 2.5 radiation dermatitis with a marked edema with superficial ulceration and a confluent moist desquamation. Patient applied StrataXRT during ongoing radiation therapy. After 3 days of topical treatment there is no longer a sign of patchy moist desquamation. Patient shows a decrease of the edema but still a persisting depigmentation of the skin. 6 Web www.civcort.com Email info@civcort.com

Radiation Dermatitis Case Studies: All patients continued radiation therapy while applying StrataXRT Case Study Spain, 2015 Hospital Universitario de Fuenlabrada, Hospital Ruber Internacional, Madrid Spain A series of case studies was performed on patients with a RTOG score of 2.5 ± 0.5. Patients and nurses reported an overall improvement, reduced itching and pain symptoms. Patients appreciated the ease of use as well as the comfort provided by StrataXRT.16 Head and neck cancer Hospital Universitario de Fuenlabrada Comunidad de Madrid Patient showing a RTOG 3 radiation dermatitis with moderate edema and a confluent moist desquamation. Patient applied StrataXRT during ongoing radiation therapy. After 19 days of topical treatment, a reduction of edema and erythema, and closure of the wound was observed. Calf muscle cancer Patient showing a severe RTOG 2 radiation dermatitis with a bright erythema and an inflammation of the scar. No signs of dry desquamation. Global Sales 800.842.8688 +1 712.737.8688 Patient applied StrataXRT during ongoing radiation therapy. After 20 days of topical treatment there is no longer a sign of the erythema. The scar shows low inflammatory signs, while the surrounding skin area has persisting depigmentation. 7

StrataXRT vs Common Treatment Regimen StrataXRT reduces the severity of radiation induced skin reactions, therefore minimizing the probabilities of not complying with the planned radiation therapy. Skincare Overall Costs During Radiation Therapy Treatment Extra nursing time needed to cut and adapt dressings Need to be carefully applied and adjusted to avoid bolus effect Not developed for radiation dermatitis No proven clinical efficacy Nursing time Physical dressings Burn cream Moisturizing cream Common treatments Cost StrataXRT StrataXRT StrataXRT No nursing time Self-applicable by patient Developed for radiation dermatitis Proven clinical efficacy How Much StrataXRT is Required StrataXRT gel is a unique formulation that requires substantially less product per application than typical moisturising creams or barrier ointments. StrataXRT 0.35 oz (10g) contains enough gel for over 1 week of treatment during a standard fractionation plan* applying the gel twice per day. StrataXRT 0.7 oz (20 g) contains enough gel for over 2 weeks of treatment during a standard fractionation plan* applying the gel twice per day. StrataXRT 1.75 oz (50 g) contains enough gel for over 5 weeks of treatment during a standard fractionation plan* applying the gel twice per day. * Standard fractionation in head and neck cancer treatment is considered to be 6 weeks. 2 weeks post radiation are expected for toxicity peak and 2 weeks more for recovery of the skin. The standard therapy time can therefore extend up to 2 weeks. us.strataxrt.com Directions for use Ensure that the affected skin or superficial wound is clean and dry. Gently pat dry as much excess exudate or wound fluid from the area as possible prior to gel application. Apply a very thin layer of StrataXRT directly to the affected area and allow the gel to dry. StrataXRT should be applied once or twice daily to the affected areas or as advised by your physician. Once dry, StrataXRT may be covered by sunscreen, cosmetics and clothing. For best results StrataXRT should be maintained in continuous contact with the skin (24 hrs/day). When applied correctly to the affected areas, StrataXRT should be dry in 5 6 minutes. If it takes longer to dry, you have probably applied too much. Gently remove the excess with a clean tissue or gauze and allow the drying process to continue. StrataXRT may also be used in conjunction with other adjunctive treatments to improve overall results. StrataXRT can be used with or without a secondary protective dressing. Recommended duration of treatment StrataXRT is recommended to be applied following the initial radiation dose and should continue to be used for a minimum of 60 90 days (24/7) post-radiation therapy, or until no further improvement is seen. For chronic radiation dermatitis, continued use is recommended until no further improvement is seen. Ingredients: Polydimethylsiloxanes, siloxanes, alkylmethyl silicones Caution: For external use only. StrataXRT should not be placed in contact with the eyes. StrataXRT should not be applied over topical medications unless advised by your physician. StrataXRT may stain clothing if not completely dry. Should your radiation dermatitis show signs of infection or failure to heal, consult your physician. If irritation occurs, discontinue use and consult your physician. Not suitable for highly exudative wounds, tunneling wounds or 3 rd degree burns. Keep out of the reach of children. Do not use after the expiration (EXP) date printed on the tube. STERILE UNTIL OPENED CV-US-001-2-0318 References: 1 Porock D & Kristjanson L. Eur J Cancer Care. 1999;8:143 153 2 Kedge E. Radiography 2009;15:247 257 3 Wells M et al. Radiation skin reactions. In: Faithfull S et al. Supportive care in radiotherapy. London: Elsevier; 2003. p. 135 159 4 Naylor W & Mallett J. Eur J Oncol Nurs. 2001;5(4):221 233 5 López E, Nuñez MI, Guerrero MR et al. Breast Cancer Res Treat. 2002;73(2):127 134 6 Hymes S et al. J Am Acad Dermatol. 2006;54(1):28 46 7 Bolderston et al. Supportive Care in Cancer 2006;14(8):802 817 8 McQuestion. Seminars in Oncology nursing 2006;22(3):163 173 9 Wickline. Oncology nursing forum 2004;31(2):237 244 10 Bernier J. et al. Ann Oncol. 2008 Jan;19(1):142-9 11 Trueman E. The Princess Royal Radiotherapy Review Team. 2011 12 Losi P et al. J Mater Sci Mater Med. 2012;23(9):2235 43 13 Data on file, Stratpharma AG, Basel, Switzerland, 2015 14 Data on file, Stratpharma AG, Basel, Switzerland, 2017 15 Data on file, Stratpharma AG, Basel, Switzerland, 2015 16 Data on file, Stratpharma AG, Basel, Switzerland, 2015 Manufactured by: Stratpharma AG, Aeschenvorstadt 57, CH-4051 Basel, Switzerland Class I Medical Device FDA Listed Global Sales Office 1401 8 th Street SE, USA Orange City, IA 51041 800.842.8688 +1 712.737.8688 info@civcort.com www.civcort.com COPYRIGHT 2018. CIVCO IS A REGISTERED TRADEMARK OF CIVCO MEDICAL SOLUTIONS. ALL OTHER TRADEMARKS ARE PROPERTY OF THEIR RESPECTIVE OWNERS. ALL PRODUCTS MAY NOT BE LICENSED IN ACCORDANCE WITH CANADIAN LAW. 2018P1367US REV. B