Real-World Evidence of an Emollient Device for Atopic and Contact Dermatitis in Pediatric to Adult Patients - Data from a Post-Marketing Surveillance.

Purpose: Atopic and contact dermatitis have been attributed to skin barrier abnormalities, immune system dysfunction and inflammation leading to pruritus. As these factors may involve oxidative stress, emollient devices containing antioxidants furfuryl palmitate and tocopherol may help reduce itching and inflammation. In this study, a post-marketing questionnaire was carried out of 40 users of a novel emollient device containing furfuryl palmitate and tocopherol (Relizema™ cream), who purchased it from a pharmacy or health-care professional to ascertain the emollient device's action on itching, flushing and moisturizing. Patients and Methods: The post-marketing questionnaire, administered by trained pharmacy and health-care staff, collected data on age; diagnosis; number of times per day and for how many days the emollient device was applied; whether the product helped alleviate itching and flushing, and in what time frame if so; and how their skin felt after using the emollient. Results: Most patients had atopic dermatitis (n = 25) or irritant contact dermatitis (n = 10); most were aged ≥19 years (n = 20) or between 3 and 12 years (n = 12). Most used the emollient device twice a day (n = 26) or more (n = 11) with 27 using it for ≤30 days. Patients predominantly reported that the emollient device "significantly improved" itching (n = 34) and flushing (n = 31) with a response being noted within 1 day (n = 17) or 1 week (n = 22). All users felt the product "protected and moisturized" their skin, the product texture was "pleasant" to "excellent" and the "non-fragrance" smell was "acceptable" to "excellent". Conclusion: Use of a novel emollient device containing ingredients aimed at managing atopic or contact dermatitis, including furfuryl palmitate and tocopherol, led to rapid improvements in itching and flushing. The emollient device was acceptable to the users.

Efficacy and Safety of an Antioxidant-Enriched Medical Device for Topical Use in Adults with Eczematous Dermatitis.

INTRODUCTION: Emollients reduce the severity of dermatitis-associated symptoms. Antioxidant supplementation may be helpful to control inflammatory processes and consequential skin damage. The clinical performance and safety of an emollient medical device for topical treatment enriched with antioxidant ingredients in adults with mild-to-moderate dermatitis is presented in this manuscript. METHODS: We performed a monocenter, open-label, uncontrolled clinical trial. Participants applied the product twice a day for 28 days. No other medication or moisturizer was allowed. Changes in dermatitis severity were assessed at days 14 and 28 by study investigators. Subjects self-assessed pruritus, Dermatology Life Quality Index, and product satisfaction. At the end of the study, a global evaluation of the product was done both by patient-reported outcomes and investigators' evaluations. RESULTS: Forty subjects were enrolled in the study (mean age 35 years). Treatment success was achieved in 87.5% of subjects (p < 0.0001) after 28 days. Mean Investigator's Global Assessment (IGA) and Eczema Area and Severity Index (EASI) scores decreased at days 14 and 28 (p < 0.0001). Subjects reported a reduction in pruritus severity and improvement of quality of life (p < 0.0001), along with satisfaction with the product. At the end of the study, skin condition improved in more than 90% of subjects. No safety issues were identified. CONCLUSION: The medical device studied for topical use in this clinical trial is considered safe and reduces pruritus in adults with atopic and contact dermatitis.

A review on the role of moisturizers for atopic dermatitis.

Effective management of atopic dermatitis (AD) involves the treatment of a defective skin barrier. Patients with AD are therefore advised to use moisturizers regularly. To date, there are few comparative studies involving moisturizers in patients with AD, and no classification system exists to objectively determine which types of moisturizers are best suited to specific AD phenotypes. With this in mind, a group of experts from allergy and immunology, adult and pediatric dermatology, and pediatrics centers within Southeast Asia met to review current data and practice, and to develop recommendations regarding the use of moisturizers in patients with AD within the Asia-Pacific region. Chronicity and severity of AD, along with patient age, treatment compliance, and economic background should all be taken into account when selecting an appropriate moisturizer for AD patients. Other considerations include adjuvant properties of the product, cosmetic acceptability, and availability over the counter. Well-defined clinical phenotypes of AD could optimally benefit from specific moisturizers. It is hoped that future studies may identify such differences by means of filaggrin mutation subtypes, confocal microscopic evaluation, pH, transepidermal water loss or presence of allergy specific IgE. Recommendations to improve the regular use of moisturizers among AD patients include measures that focus on treatment compliance, patient and caregiver education, appropriate treatment goals, avoidance of sensitizing agents, and collaboration with other relevant specialists.