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Acute radiodermatitis is the most common side effect in non-melanoma skin cancer patients undergoing radiotherapy. Nonetheless, despite the ongoing progress of clinical trials, no effective regimen has been found yet. In this study, a non-woven patch, comprised of electrospun polymeric micro/nanofibers loaded with an aqueous extract of Pinus halepensis bark (PHBE), was fabricated and clinically tested for its efficacy to prevent radiodermatitis. The bioactivity of the PHBE patch was evaluated in comparison with a medical cream indicated for acute radiodermatitis. Twelve volunteer patients were selected and randomly assigned to two groups, applying either the PHBE patch or the reference cream daily. Evaluation of radiation-induced skin reactions was performed during the radiotherapy period and 1 month afterwards according to the Radiation Therapy Oncology Group (RTOG) grading scale, photo-documentation, patient-reported outcomes (Visual Analog Scale, questionnaire), biophysical measurements (hydration, transepidermal water loss, erythema, melanin), and image analysis. In contrast with the reference product, the PHBE patch showed significant anti-inflammatory activity and restored most skin parameters to normal levels 1 month after completion of radiation therapy. No adverse event was reported, indicating that the application of the PHBE patch can be considered as a safe medical device for prophylactic radiodermatitis treatment.

Simple Summary The most frequent adverse effect for patients receiving radiotherapy, an effective treatment for skin cancer when surgical removal of the tumor is impossible, is acute radiodermatitis, affecting patients’ physical function and often leading to therapy termination. Creams and other topical formulations used so far for the prevention of acute radiodermatitis are applied at regular intervals but do not ensure a constant and controlled transepidermal absorption. The aqueous extract of Aleppo pine bark, previously preclinically and clinically assessed in the form of gel, was herein loaded on micro/nanofibrous patches and clinically evaluated in comparison with a commercially used reference cream on non-melanoma skin carcinoma patients undergoing radiotherapy. The experimental patch significantly contributed to prophylaxis and successful management of acute radiodermatitis, safely restoring skin and its biophysical parameters to normal levels and reducing patients’ discomfort. Topical application of pine-loaded micro/nanofibrous patches holds great potential for the development of a new generation of anti-inflammatory skin care dressings against radiodermatitis. Abstract Acute radiodermatitis is the most common side effect in non-melanoma skin cancer patients undergoing radiotherapy. Nonetheless, despite the ongoing progress of clinical trials, no effective regimen has been found yet. In this study, a non-woven patch, comprised of electrospun polymeric micro/nanofibers loaded with an aqueous extract of Pinus halepensis bark (PHBE), was fabricated and clinically tested for its efficacy to prevent radiodermatitis. The bioactivity of the PHBE patch was evaluated in comparison with a medical cream indicated for acute radiodermatitis. Twelve volunteer patients were selected and randomly assigned to two groups, applying either the PHBE patch or the reference cream daily. Evaluation of radiation-induced skin reactions was performed during the radiotherapy period and 1 month afterwards according to the Radiation Therapy Oncology Group (RTOG) grading scale, photo-documentation, patient-reported outcomes (Visual Analog Scale, questionnaire), biophysical measurements (hydration, transepidermal water loss, erythema, melanin), and image analysis. In contrast with the reference product, the PHBE patch showed significant anti-inflammatory activity and restored most skin parameters to normal levels 1 month after completion of radiation therapy. No adverse event was reported, indicating that the application of the PHBE patch can be considered as a safe medical device for prophylactic radiodermatitis treatment.

Background/aim Cigarette smoke (CS) is a major environmental health threat. The oxidative stress induced by CS on keratinocytes and the possible protective effect of nicotine, its receptor inhibitors, and Pinus halepensis bark extract in relation to known antioxidants were investigated. Materials and methods Primary mouse keratinocytes were exposed to cigarette smoke in the presence and absence of Pinus halepensis bark extract (1 μg/ml), rutin (50 μM) and ascorbic acid (250 μM), nicotine (1 μM) with or without mecamylamine (5 μM) and α-bungarotoxin (0.1 μM). Keratinocyte viability and oxidative stress were evaluated by MTT and fluorescence assays. Results Pinus halepensis bark extract decreased the oxidative stress and increased the viability of keratinocytes, and moreover, these effects were more pronounced compared to the mixture of rutin and L-ascorbic acid. Nicotine significantly enhanced the viability potentiation of the beneficial effect induced by Pinus halepensis bark extract. Mecamylamine and α-bungarotoxin showed no specific effect. Conclusion Pinus halepensis bark extract in combination with nicotine may successfully reverse skin damage induced by cigarette smoke.

Skin inflammation is the most common symptom in dermatological diseases. It is usually treated by topically applied products, such as creams, gels and lotions. Skin dressings offer a promising alternative as they are endowed with more controlled administration conditions. In this study, the anti-inflammatory activity of electrospun alginate micro/nanofibrous dressings loaded with the aqueous extract of Pinus halepensis bark (PHBE) was evaluated in vivo in mice. The upper back skin of SKH-1 female hairless mice was exposed to a single dose of ultraviolet radiation (3 MEDs) and the inflamed area was treated daily by the direct application of a nanofibrous patch. The condition of the skin was evaluated primarily on the basis of clinical observation, photo-documentation and histopathological assessment, while measurements of the erythema, hydration, transepidermal water loss (TEWL) and sebum production were also taken into account. The results showed that the topical application of alginate micro/nanofibrous dressings loaded with PHBE on UV-inflamed skin significantly attenuated inflammation damage, reducing the healing period. Increase of the loading dose of PHBE resulted in a proportional reduction of the extent, the density and the depth of skin inflammation. With the steadily increasing interest of the skin dressing industry towards nanofibrous matrices, electrospun nonwovens could serve as ideal candidates for the development of multifunctional anti-inflammatory care systems.