A study to compare a Fixed Dose Combination of Mometasone Furoate 0.1% + Fusidic Acid 2% Cream and Fixed Dose Combination of Betamethasone Valerate 0.1% + Neomycin Sulphate 0.5% Cream in Patients suffering from infected eczema
- Conditions
- Health Condition 1: null- Infected Dermatoses
- Registration Number
- CTRI/2011/091/000062
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd Glenmark House B D Sawant Marg Chakala Andheri East Mumbai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 192
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
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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1.To evaluate and compare the Bacteriological Response from baseline to the end of treatment in patients between two treatment group <br/ ><br>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. <br/ ><br>3.Overall Global Assessment of Efficacy by Investigator and PatientTimepoint: Baseline, Visit 2 and Visit 3