The regimen was well tolerated and no serious product-related adverse events were observed. 

Daily Avena Sativa (Oat) skincare regimen provides a significant improvement in xerosis and pruritus for adult patients undergoing systemic oncology treatments,according to research presented at the American Academy of Dermatology (AAD) Virtual Meeting Experience (VMX) 2021.

"The ultimate goal of cancer therapy is to save lives, which often involves taking an aggressive approach to treatment that may lead to side effects, including degradation of the skin barrier," says Caroline Tillett, Global Head R&D, Johnson & Johnson Consumer Health, in a news release. "We are pleased to present the results from among the first clinical studies examining a daily over-the-counter skincare regimen showing significant improvement for cancer patients' skin." 

Patients enrolled in the study reported common side effects of mild-to-moderate xerosis (µ=1.5) and pruritus (µ=0.9) related to their cancer treatment. Patients used an Avena Sativa Skincare Regimen for five weeks, which included: 

• Aveeno's Restorative Skin Therapy Sulfate-Free Body Wash used once-a-day for all showering. The body wash contains antioxidant oat, aloe, and pro-vitamin B5. 
• Aveeno's Restorative Skin Therapy Oat Repairing Cream applied twice daily. The body cream contains prebiotic oat concentrate, aloe, and pro-vitamin B5. It is formulated without parabens, fragrance, phthalates, and steroids. 
• Aveeno's Restorative Skin Therapy Itch Relief Balm applied as needed. The anti-itch balm is formulated with prebiotic oat concentrate, aloe, pro-vitamin B5, and pramoxine HCl. The targeted treatment is formulated without parabens, fragrance, phthalates, and steroids. 

After five weeks, significant improvements (p<0.05) in xerosis (µ=0.5) and pruritus (µ=0.4) were observed according to dermatologist reported Common Terminology Criteria Adverse Events (CTCAE) scoring and Patient Reported Outcomes Common Terminology Criteria Adverse Events (PROCTCAE) scoring. The regimen was well tolerated and no serious product-related adverse events were observed. 

Patients also reported significant improvements (p<0.05) in skin moisture with the regimen. They perceived significant improvements in their Quality of Life as measured by Skindex-16 scores including their symptoms, emotional, and functional impact. 

The Role of the Skin Barrier in Cancer Treatment Side Effects

Cancer treatment with kinase inhibitors often results in skin-related side effects, also known as Cutaneous Adverse Drug Reactions (CADRs), which can significantly impact patients' quality of life. Examples of CADRs are skin inflammation, infections, itch, and other symptoms, and are frequent following administration of Epidermal Growth Factor Receptor inhibitors (EGFRis). 

In a Johnson & Johnson Consumer Health and Janssen Pharmaceutical Companies of Johnson & Johnson analysis examining the effects of eight EGFRis and Vascular Endothelial Growth Factor Receptor inhibitors (VEGFRis) (3, 10, 30, 100nM) on human keratinocytes in a novel 3D micro-skin tissue culture model, results demonstrated that cancer treatment can directly impact cell growth and differentiation on the surface of the skin. 

"The skin barrier is greatly impacted by certain cancer treatments. As the skin cells normal programming is altered, the skin barrier is damaged, allowing water to escape more easily and irritants to more easily penetrate the skin," says Dr. Georgios Stamatas, Research Associate Director and Fellow, Johnson & Johnson Consumer Health. "Johnson & Johnson Consumer Health and Janssen Pharmaceutical Companies of Johnson & Johnson have shown with this latest research that we can significantly improve mild-to-moderate skin-related side effects with topical solutions, helping patients focus on their cancer treatment." 

In a full thickness reconstructed human epidermis (RHE) model a decrease in trans-epidermal water loss (TEWL) rate was observed, indicating the skin barrier was compromised. The study showed that topical treatment of the RHE with emollient formulations during EGFRi treatment can reduce, or even completely inhibit, the TEWL increase resulting from treatment with EGFRis. The study showed that topical emollients can help improve skin barrier damage and subsequent skin irritations.