Comparison of desoximetasone and mometasone cream in patients of eczema

Not Applicable

• Conditions: Health Condition 1: null- Eczema

• Registration Number: CTRI/2018/03/012300
• Lead Sponsor: Emcure Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 <br/ ><br>Day 14 and Day 21 from baselineTimepoint: Baseline, Days 14 and 21;Proportion of patients showing treatment success as assessed by Physiciansâ?? Global <br/ ><br>Assessment (PGA) score at Day 14 and Day 21 from baseline.Timepoint: Day 14 and 21