A Clinical Trial to study the effects of a fixed dose cream formulation of Mometasone 0.1% +Fusidic acid 2% in patients with steroid responsive dermatoses with secondary bacterial infections
- Registration Number
- CTRI/2010/091/000483
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Male & female (post-menopausal, surgically sterilized or practicing a reliable method of birth control) patients with age ranging from 12 to 65 years.
Clinical diagnosis of patients with infected dermatoses
Written informed consent by patient.
Patient willing to follow up.
Pregnant and lactating women.
Serious skin disorders, dyspigmentation and extensive scarring in the affected areas.
Hypersensitivity to Mometasone or Fusidic acid or cream base.
Immuno-compromised states and patients with systemic infections.
Patients who have participated in a new drug study in the past 6 months.
Patients with severe cardiac, hepatic, renal, or cerebrovascular disease, malignancy, chronic uncontrolled systemic diseases e.g., diabetes, hypertension, asthma, collagen disorders, etc. or any other serious medical illness.
Any other condition that in the opinion of the investigator does not justify the patient?s participation in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bacteriological eradicationTimepoint: Baseline, and Day 13-14;Clinical signs and symptoms, Severity of lesions, discharge from lesions.Timepoint: Baseline, Days 6-7 and Days 13-14
- Secondary Outcome Measures
Name Time Method Global assessment of efficacy of treatment by Physicians and patientsTimepoint: End of the study