Health Condition 1: null- Eczema
Conditions
Interventions
Intervention1: Desoximetasone: 0.25% emollient cream
Control Intervention1: Mometasone: 0.1% cream
Sponsors
Emcure Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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 dermatologistâ??s discretion and approved Prescribing Information 4. Patients/ Legally Authorized Representative (LAR) willing to give written informed consent
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients developing adverse events with Desoximetasone 0.25% emollient cream during the 3 week treatment period in comparison to mometasone cream and nature of adverse eventsTimepoint: Days 14 and 21 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Eczema Area and Severity Index (EASI) score at Day 14 and Day 21Timepoint: Baseline, Days 14 and 21;Change in Visual Analog Scale (VAS) for perception of improvement in intensity of pruritus at Day 14 and Day 21 from baselineTimepoint: Baseline, Days 14 and 21;Proportion of patients showing treatment success as assessed by Physiciansâ?? Global Assessment (PGA) score at Day 14 and Day 21 from baseline.Timepoint: Day 14 and 21 | — |
Countries
India
Contacts
Public ContactAnirudha Potey
Emcure Pharmaceuticals Ltd
Outcome results
None listed