Assessment of Safety and Effectiveness of Desoximetasone Emollient Cream 0.25% in Comparison to Mometasone Cream 0.1% in Patients with Eczema: MCOR Study

This prospective, observational, multi-center, post marketing surveillance study has been planned to gather real-world clinical comparative data on the effectiveness and safety of desoximetasone emollient cream versus mometasone cream in 180 Indian patients suffering from eczema. The objective of the study is to evaluate the safety of Desoximetasone 0.25% emollient cream in comparison to mometasone cream 0.1% in patients with eczema during 3 weeks of therapy. Safety will be assessed as the proportion of patients suffering from adverse events during the study and the nature of the adverse events. The effectiveness will be assessed by proportion of patients showing treatment success as assessed by Physicians’ Global Assessment (PGA) score at Day 14 and Day 21 from baseline, change in Visual Analog Scale (VAS) for perception of improvement in intensity of pruritus at

Day 14 and Day 21 from baseline, and change in Eczema Area and Severity Index (EASI) score at Day 14 and Day 21. The study will be conducted at 9 sites in India over a study duration of 6 months. The inclusion criteria will be - 1. Patients >10 years of age of either gender who are capable of complying with protocol requirements 2. Newly diagnosed, treatment-naïve patients with clinical diagnosis of eczema 3. Patients treated with desoximetasone 0.25% emollient cream or mometasone cream 0.1% as per dermatologist’s discretion and approved Prescribing Information 4. Patients/ Legally Authorized Representative (LAR) willing to give written informed consent. The exclusion criteria will be 1. Patients with history of hypersensitivity to any of the components of study medication preparations. 2. Pregnant and nursing women 3. Patients with documented comorbid systemic disorders of the cardiovascular, central nervous, gastrointestinal, respiratory systems, hormonal disorders, and chronic inflammatory conditions, which, in the opinion of the investigator may have a potential health risk to the patient.4. Patients consuming oral immunosuppressive medications including oral corticosteroids etc prior to 3 weeks of study.5. Patients with documented disorders related to present or past history of abnormal activity of Hypothalamo-pituitary-adrenal axis. Patient’s information and demographics will be recorded. In demographics, the age, sex, and comorbid conditions will be noted. The severity of disease and extent of body involvement will be noted by the investigator. The severity of disease will be assessed by grading (0 - None, 1 – Mild, 2- Moderate, 3 -Severe) for each signs viz. erythema, edema/population, excoriation and lichenification in 4 different regions of head/neck, trunk, upper and lower extremities. For each region, the average of severity will be considered. For assessing the extent of the disease, percentage involvement of each of the 4 regions will be noted. From this data, EASI score will be calculated. Patient’s response to intensity of pruritus will be noted using a VAS score.