Miaderm® Radiation Relief Lotion & Miaderm-L

1. Radiation Dermatitis and Treatment Strategies Patrick Linson MD MPH President Miaderm at Aiden Industries

2. Cancer • Second leading cause of death in USA • 2 out of 3 people will get radiation as part of their cancer treatment • Over 90% of radiation patients will have adverse skin effects.

3. Radiation Effects Acute and Chronic • Acute • Can occur up to 3 months after initiation of treatment • Most frequently occur within 4 weeks of treatment • Epidermal regeneration within 3 to 5 weeks after treatment. • Complete healing within 3 months • Chronic • Can occur 3 months after initiation of treatment.

4. The Integument

5. Epidermis • Outermost layer of skin • No blood vessels • Stratified squamous epithelium (melanocytes, langerhans, merkel cell, and keratinocytes) • Five layers Stratum germinativum, stratum spinosum, stratum granulosum, stratum lucidum, stratum corneum

7. Toxicity • Acute • destroys stem cells • chemotherapy effects on epithelial stem cell • can see more additive effects with chemo

8. Acute Skin Reaction • With Standard Fractionation • 10 to 14 days • transit time for new skin cells to migrate from basement membrane to surface • Skin care goal to maintain outer layer

9. Radiation Dermatitis

10. Toxicity • Late Toxicity • Damage from insufficient DNA repair • Occurs months to years after radiation therapy

11. Risk Factors for Late Toxicity • Total Dose and Volume irradiated • Fraction size (Greater than 2 Gy) • Concurrent chemo • Co-morbid illness (DM, RA, Scleraderma) • Vascular disease

12. Late Effects

13. NCI CommonToxicity Criteria • Grade 1 • faint erythema • dry desquamation

14. NCI CommonToxicity Criteria• Grade 2 • Moderate to brisk erythema • Patchy moist desquamation confined to skin folds • Moderate edema

15. NCI CommonToxicity Criteria • Grade 3 • Moist desquamation other than skin folds • Bleeding induced by trauma or abrasion

16. NCI CommonToxicity Criteria • Grade 4 • Skin necrosis or ulceration to dermis

17. Radiodermatitis Managment • General Principles • Avoid Pain and Discomfort • Reduce Infection Risk • Emotional and Psychological Distress • Avoid Treatment Breaks

18. Radiation Breaks Russo et al found unplanned radiation treatments breaks in head and neck cancer cases increase LR and OS.. 8 to 30% of patients will go on an unplanned break, many as a result of Radiation Dermatitis. Decrease LC by 1.4% per day missed. Russo et al. Oncologist 13, 886-898. 2008

19. Evidence Based Approach • Skin care • Products • Techniques

20. Skin Care • Washing • Campbell et al. PRCT comparing breast and chest wall patients to not washing, washing with water, washing with soap. • Subjective and objective measurements showed improvement with washing (soap or no soap) when compared to not washingCampbell et al. Clin Oncol (R Coll Radiol). 1992 Mar;4(2):78-82.

21. Skin washing • Roy et al. PRCT comparing no washing to washing with soap and water • Median scores pain, itching, and burning were higher in non washing group (trend) with MVA found weight, conc chemo, and hot spots on dosimetry trend toward more toxicity in non washing group. Roy et al. Radiother Oncol. 2001 Mar;58(3):333-9

22. Hair Washing • Westbury et al. PRCT 109 patients getting WB RT randomized to hair washing and no hair washing • RTOG criteria showed no statistically sig difference in each group.

23. Skin care • Skin washing • Loose clothing • Natural fibers • Avoid perfumes • avoid electric razors • No excessive temperatures, wind, sun • Avoid tape • Avoid deodorants

24. Water Based Cream • Australian PRCT of 225 breast undergoing RT after conservative surgery randomized to aqueous cream vs Aloe Vera Gel during RT • Aqueous cream showed stat sig in reducing dry desquamation and pain related to treatment (Heggie S, et al. Cancer Nurs. 2002; 25(6):442-51)

25. Steroid Cream • Swedish PRCT of 49 BCT patients undergoing RT comparing Emolient Cream vs Mometasone Furoate (MMF) Cream • Stat Sig Difference in reducing radiation dermatitis in MMF Steroid Cream • There was no change in erythema or hyperpigmentationBostrom et al. Radiother Oncol. 2001 Jun;59(3):257-65.

26. Petrolatum • Indian PRCT of 51 patients who after MRM assigned to betamethasone 0.1%, petrolatum, or nothing • Reduction in Radiation dermatitis in the steroid group alone when compared to nothing or petrolatum Omidvari S, et al. Indian J Dermatol Venerol Leprol. 2007; 73(3):209

27. Calendula • French PRCT 254 pts who had BC surgery followed by RT randomized to Calendula based cream vs Biafine • Pt and physician assessed tools Pommier P, et al. J Clinical Oncol. 2004; 22:1447-1453

28. Calendula• Grade 2 or hight dermatitis was lower in Calendula • Less pain (45% vs 65%) in Calendula group • Satisfaction improved in Calendula group • 15 vs 1 treatment breaks in Calendula group • Chemotherapy and BMI increased risk for radiation dermatitis on MVAPommier P, et al. J Clinical Oncol. 2004; 22:1447-1453

29. Hyaluronate • Swiss PRCT of 152 head and neck, breast, or pelvic patients treated with RT randomized to Hyaluronate Cream vs Placebo Cream • Reduced incidence, delayed onset, and faster recovery high grade skin reaction.Ligouri V, et al. Radioth Oncol. 1997; 2:155-161

30. Aloe Vera • Multiple Negative Studies • Olsen et al. Univ of Miami PRCT Soap and water vs soap and Aloe Vera • Showed delayed skin reaction. Suggestion of preventive effect. Patients with less pain. Olsen DL, et al. Oncol Nurs Forum. 2001; 28:543-247

31. Aloe Vera • Brazil PRCT comparing Aloe Gel to BSC • Sig reduction in grade 2 or higher radiation dermatitis (29% vs 44%) • 29 patients getting betamethasone cream and reactions were not different IJROBP in press

32. In Summary • Washing Skin and hair Helpful • Beneficial in reducing pain or radiation dermatitis • Steroidal Cream • Water based cream • Hyaluronate • Calendula • Aloe Vera

33. Introducing Miaderm® • Water based • Calendul a • Hyaluronic acid • Aloe Vera

34. Miaderm® Radiation Relief Lotion • Made in laboratory in USA • Natural Ingredients providing preventative care • Non-steroidal • Alcohol and nut oil free • Marine collagen • Useful beyond radiation treatment • 100% unconditional satisfaction guaranteed

35. 35 Same science of Miaderm® with 4% Lidocaine HCI FDA approved for over the counter use Developed for patients who are more susceptible and need extra relief. Eliminates the need for additional applications of lidocaine For treatment areas that have skin folds and extra help is needed. For patients who failed to use Miaderm® from the beginning of treatment Also used for the pain associated with Shingles 100% unconditional satisfaction

36. Effectiveness of Miaderm® vs the others

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Miaderm® Radiation Relief Lotion & Miaderm-L

Miaderm® Radiation Relief Lotion & Miaderm-L

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