Health Condition 1: null- Acute and Chronic Infected Eczematous Dermatitis
Conditions
Interventions
Intervention1: Halometasone 0.05%w/w &
Fusidic Acid 2%Topical Cream: BD for 20 days -Acute and 30 days -Chronic
Control Intervention1: Betamathasone valerate 0.12% w/w & Neomycin sulphate 0.5% w/w topical cream: BD 20 days -Acute , 30 days
Sponsors
Dr Reddys Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Adults male and females with infected eczematous dermatosis aged > 18 years
Exclusion criteria
Exclusion criteria: History of hypersensitivity to any of the drugs or stated excipients Unwilling to give written informed consent Uncontrolled Diabetes mellitus Recent tubercular, syphilitic or viral skin infections Concomitant diseases ?Leukemia, Parasitic diseases (i.e.Scabies, Pediculosis) or hypogammaglobulinemia Patient in need of any form of treatment which influences the healing of the lesion such as topical treatment other than trial preparation, topical radiation therapy, systemic medication with antibiotics, antimicrobials, antihistaminic, cytostatics, corticosteroids or ACTH. Pregnant and nursing women Patients with clinically significant cardiovascular, hematological, pancreatic, metabolic, neurological or clinically significant laboratory abnormalities, which in the judgement of the investigator, would interfere with, subject participation in the study or evaluation of subject?s response to therapy. Inclusion of the subject more than once in this trial is not allowed. Participation in any other clinical trial involving investigational products within 30 days of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in the EASI Score (Eczema Area and Severity Index score) at all visits. Reduction of bacterial counts of infected lesion (assessed on Day 0 before initiating treatment, on Day 10 and at EOT Timepoint: Screening and at each visit | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Improvement in severity of pruritis 2.Reduction in eczema severity grade as assessed on IGA scaleTimepoint: At each follow up visit | — |
Countries
India
Contacts
Public ContactDrShilpi Dhawan
Outcome results
None listed