Health Condition 1: null- Infected Dermatoses
Conditions
Interventions
Intervention1: Mometasone Furoate 0.1% + Fusidic Acid 2% Cream: Cream, applied topically twice daily for two weeks
Control Intervention1: Betamethasone Valerate 0.1% + Neomycin Sulphate 0.5%: Cream,ap
Sponsors
Glenmark Pharmaceuticals Ltd Glenmark House B D Sawant Marg Chakala Andheri East Mumbai
Glenmark Pharmaceuticals Ltd Glenmark House B D Sawant Marg Chakala Andheri East Mumbai
Eligibility
Inclusion criteria
Inclusion criteria: Patient with age 12 yrs and above of both gender Clinical diagnosis of patients with Infected Dermatoses with lesion size of at least 2x2 cms Written informed consent by patient/patient?s guardian Patient willing to follow up Patients with Neutrophils and Gram Positive Cocci on Primary Smear Examination Patients with a minimum score of 1 on the Total Severity Score
Exclusion criteria
Exclusion criteria: Pregnant or lactating females or wishes to become pregnant during study period Patient known to have hypersensitivity to either Mometasone, Fusidic acid, Neomycin and/ Betamethasone Valerate or oral antibiotics or drugs of similar class Patient not willing to participate in the trial or not in position to give the informed consent Patients who have already received local or systemic antibiotic or any topical therapy in the last 72 hour prior to inclusion Patients having severe infection requiring systemic antibiotic, in the opinion of the treating dermatolo¬gist Patients with Diabetes mellitus or on Antidiabetic Therapy Participation in any other clinical trial involving investigational products within 30 days of screening Patients with Clinical diagnosis of Viral or Fungal Skin Infections Patients with skin lesions such as scarring or hyperpigmentation which may confound the assessment Patients with predominant Gram negative flora or polymicrobial flora comprising both Gram Positive Cocci and Gram Negative organisms on smear examination Patients who had received Systemic Immunosuppressives or Oral Steroids within the previous 2 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate and compare the reduction in Total Severity Score of Signs and Symptoms from baseline to the end of treatment in patients between two treatment groupsTimepoint: Baseline, Visit 2 and Visit 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate and compare the Bacteriological Response from baseline to the end of treatment in patients between two treatment group 2.To evaluate the Safety and Tolerability of Fixed Dose Combination of Mometasone Furoate 0.1% + Fusidic Acid 2% Cream vs. Fixed Dose Combination of Betamethasone Valerate 0.1% + Neomycin Sulphate 0.5% Cream in patients suffering from Dermatoses with Secondary Bacterial Infection. 3.Overall Global Assessment of Efficacy by Investigator and PatientTimepoint: Baseline, Visit 2 and Visit 3 | — |
Countries
India
Contacts
Public ContactDr Samuel Matte
Medical Services
Outcome results
None listed