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.
BACKGROUND: Atopic dermatitis (AD) is a chronic inflammatory disease. Recently, dupilumab was approved for moderate-to-severe AD. D-OCT is a noninvasive tool for the characterization of skin diseases. OBJECTIVE: To describe the changes observed with D-OCT in lesional and clinically healthy skin of patients with refractory severe AD under dupilumab treatment. METHODS: We analyzed AD lesions and healthy skin by D-OCT. Clinical scores of AD severity were assessed at baseline (T0) and after 1 and 3 months of treatment (T1, T2). Descriptive statistics, chi-square test, and t test were used to compare the analyzed parameters over time and between AD lesions and clinically healthy skin. RESULTS: At baseline, average EASI was 45.7. During the follow-up, EASI75 and EASI90 were achieved in 57% and 36% of patients at T1 and 100% and 86% of patients at T2, respectively. Lesional skin D-OCT parameters related to epidermal remodeling and inflammation evidenced a significant improvement after 1 month of treatment. In clinically healthy skin, D-OCT parameters improved significantly after 3 months of treatment, especially for collagen remodeling and inflammation. CONCLUSION: The study demonstrates that the clinical improvement of severe AD patients under dupilumab treatment is correlated with specific D-OCT changes of patients' lesional and clinically healthy skin.
Antibodies, Monoclonal, Humanized/therapeutic use , Dermatitis, Atopic , Tomography, Optical Coherence , Dermatitis, Atopic/diagnostic imaging , Dermatitis, Atopic/drug therapy , Humans , Treatment Outcome
INTRODUCTION: Omalizumab is indicated for the treatment of patients affected by chronic spontaneous urticaria (CSU) refractory to antihistamines. The aim of this study was to assess the efficacy, safety, and recurrence of symptoms in a real-life experience of omalizumab as an add-on therapy for H1-antihistamine-refractory CSU patients (refractory CSU). METHODS: A retrospective review of the clinical records of all refractory CSU treated with omalizumab at our dermatology center from June 2014 to April 2017 was performed. Patients previously treated with second-generation antihistamines at a fourfold increased dose without clinical responses at 4 weeks of treatment were selected. Omalizumab was administered at a single dosage of 300 mg every 4 weeks for 6 months. Disease severity was assessed using the 7-day Urticaria Activity Score (UAS7). RESULTS: Eighteen patients (14 women; mean age 51 years, range 25-74) were enrolled. Mean UAS7 at baseline was 27.3 (range 15-38). Symptoms improved in all patients at 4 weeks (UAS7 = 16.1, range 0-36). Treatment was completed in 17 patients (94.4%), and among these, a complete response (UAS7 = 0) was registered in 10 patients (58.8%). Adverse events included thrombocytopenia in 1 patient (5.6%) at 16 weeks; therapy was suspended after 20 weeks and the complication was resolved, resulting in a freedom from major adverse events of 94.4%. Symptom recurrence occurred in 3 patients (17.6%) at 4, 5, and 7 months from the end of the primary therapy. Retreatment with omalizumab was successful without any adverse effects. Mean follow-up was 9.5 months (range 1-28). CONCLUSION: Add-on omalizumab therapy for refractory CSU in a real-life setting seems to be effective and safe with a relatively low incidence of symptom recurrence. Further research should investigate personalized omalizumab treatment dosages and administration intervals, and the identification of biomarkers for future treatment algorithms.
