This multicenter, observational study, conducted on a cohort of 319 patients treated for cancer with xerosis, demonstrated that daily use of the emollient PLUS in real-life conditions led to a significant decrease in xerosis severity, regardless of the anticancer therapy received. The study product was also effective at reducing the severity of other dermatologic clinical signs related to xerosis, including desquamation, erythema, pruritus, and tightness of the skin, as well as pain and sleep disturbance. In addition, use of the emollient substantially lessened the impact of the skin symptoms on patient QoL. The vast majority of physicians and patients reported that the effectiveness of the product was good, and overall clinical success was achieved in a high proportion of patients, particularly among those that received hormonotherapy. The product was well tolerated, with no clinically significant AEs reported.
The wide range of available anticancer therapies has greatly improved the management of many malignancies, but these treatments often induce uncomfortable and aesthetically disturbing cutaneous reactions, such as xerosis, that can have a rapid and significant impact on patient self-esteem, social relationships, and QoL [3, 14]. The effectiveness of dermocosmetic products is generally less well documented than that of pharmaceutical treatments and their use is less strictly regulated. However, in recent years, an increasing number of studies have investigated the benefits of skin care products, such as emollients or creams, on the management of cutaneous AEs in various populations, including oncology patients [26,27,28,29]. A real-world study in an African population showed that an 8-week regimen with a glycerol-based emollient could lead to reductions in xerosis severity of more than 80% in adults and children, with the effects starting to be observed within the first 4 weeks of treatment . The authors also reported improvements in QoL related to this skin condition. In another study, topical formulations containing glyceryl glucoside and natural moisturizing factors for optimal water distribution, were shown to significantly reduce transepidermal water loss, decrease visible dryness and tactile roughness, and improve skin hydration over 2 weeks of regular use in women over 50 years of age, as compared with a control vehicle . Interestingly, in the regression part of this study, corneometry measurements revealed that the skin remained moisturized for several days after the product had been stopped. Some other dermocosmetic products have been more specifically designed for patients treated for cancer. For instance, two moisturizers have been found to be effective at markedly decreasing the frequency of dry skin (from 69% to 21% of subjects) and skin rash (from 8% to 1% of subjects), as well as the Skindex-16 score (from 25.05 to 16.19), a dermatology-specific QoL instrument, within 1 month of use in patients receiving various anticancer treatments alone or in combination . Similarly, a heparinoid moisturizer has been shown to help mitigate acute dermatitis following whole-breast radiotherapy in women who had previously undergone breast-conserving surgery . The prophylactic application of this moisturizer on irradiated breast skin led to improvements in skin water content and sebum levels, and relieved skin dryness, desquamation, and pain within 2 weeks of use, compared with irradiated breast skin of women who did not apply any moisturizer.
Data from these studies have thus allowed specific guidelines to be generated for both preventive and supportive skin care for patients treated for cancer [2, 32,33,34]. Indeed, skin hydration with emollients or creams is now an essential part of the general skin care recommendations for patients receiving radiotherapy, targeted therapy, or systemic chemotherapy, as all these treatments can disrupt and compromise skin barrier function [2, 10, 34]. These skin care products can therefore be considered as a first-line management option in these patients, accompanied by early counseling to help patients choose the most appropriate product to prevent worsening of their skin side effects and to minimize the impact of these side effects on their current cancer treatment, as well as on their QoL . As with all forms of xerosis, patients developing xerotic lesions after initiating anticancer therapy are now also advised to initiate treatment for their skin AEs as early as possible, and regularly use clinically tested and hypoallergenic moisturizing products. In mild cases, management with basic emollients is often sufficient [10, 35] but in more severe cases, emollients may need to be used as adjunct therapies alongside systemic or topical pharmacologic treatments to reduce inflammation or treat infections. The recent development of products regarded as emollients PLUS, i.e., those containing active nonmedicated ingredients, allows additional options to be proposed for the management of xerosis. These products may contain saponins, flavonoids, and riboflavins from protein-free oat plantlet extracts, or microbial lysates that can enhance their repairing properties and influence the skin microbiome .
The emollient evaluated in our study contains the ADE-G1 extract from the bacteria Aquaphilus dolomiae, which has been shown by in vitro studies to display several properties that are relevant for the treatment of xerosis, including immunomodulatory and antiinflammatory activities [18, 19]. In human skin, these properties could help the skin barrier self-repair processes and lessen the cutaneous inflammatory response to triggering agents . The formulation of the ADE-G1 emollient PLUS also contains omega fatty acids, ceramide, and sterols that, in addition to reducing transepidermal water loss, can replenish the lipid composition of the skin and hence strengthen its barrier function . The ADE-G1-containing emollient PLUS has been already shown to be effective in alleviating dry skin and itching symptoms in several clinical studies involving various patient populations [20, 21]. In particular, substantial decreases in xerosis and pruritus severity (−56% and −60% reductions in severity scores, respectively) were found after regular use of the emollient PLUS in real-life conditions in adult and pediatric patients with a range of dermatologic and systemic diseases . The product was also found to be beneficial for improving sleep quality and DLQI scores in these patients. It is noteworthy that the significant improvements in skin symptoms reported in this study were achieved after only a short 1-week period of product use. It is also important to highlight that in our study and in the previous studies mentioned, involving hundreds of subjects, the emollients tested were well tolerated. Overall, clinical studies with emollients and emollients PLUS support the use of these products as part of the regular skin care regime for xerosis patients in multiple populations, including the specific population of patients treated for cancer.
This study provides the first assessment of the effectiveness and tolerance of an emollient PLUS in patients treated for cancer in real-life conditions. Although the observational design of the study has some inherent limitations and did not allow a comparison of the effectiveness of the ADE-G1-containing product with that of a control vehicle, the results of our pre–post analysis gave clear and valuable insights into the benefits of the product for the management of xerosis in general clinical practice. However, the noninterventional nature of the study and its reliance on patient self-assessments may have introduced reporting bias, in particular for assessments of study product use, which was not systematically recorded using a daily diary. Although our analyses indicated that the emollient PLUS was particularly effective for patients in the hormonotherapy group, the level of significance of this finding should perhaps be interpreted with caution as the number of patients in this group was relatively small. Despite these limitations, the main effectiveness outcomes of our study were reliably assessed by the physicians using objective, validated, and noninvasive clinical assessment tools. The multicenter nature of the study also allowed the effectiveness of the product to be investigated in a large number of patients. Moreover, even though the product was not specifically tailored for cancer patients, our before-and-after approach showed it was effective for rapidly relieving xerosis and associated symptoms in these vulnerable and sensitive patients. Contrary to other real-world studies [21, 30, 36], most patients included in our study were prescribed the emollient PLUS without any concurrent medication for xerosis (75.3% of patients), allowing us to make clear assessments supporting the effectiveness of the product as a standalone treatment for mild xerosis. It is also noteworthy that the improvements in dermatological symptoms and QoL were observed in all anticancer treatment groups, demonstrating the generalizability of our findings, regardless of the type of anticancer treatment received.
Future studies could be designed to further determine if the improvements in symptoms resulting from the regular use of the emollient PLUS are sustained over longer periods; this would be especially relevant for oncology patients as their cancer treatments are usually administered over several months. Furthermore, the preventive effect of the study product could also be specifically evaluated in future studies. Indeed, it would be interesting to test our product as a prophylactic treatment as previous studies, such as those evaluating preemptive measures to mitigate the skin toxicities associated with epidermal growth factor receptor inhibitor treatments for metastatic colorectal cancer, have already indicated that this approach could be more effective for cutaneous AEs than reactive treatments [26, 33].