A clinical study to study the effects of a cream containing a fixed -dose of Halobetasol propionate and Fusidic acid in patients with infected dermatoses
- Registration Number
- CTRI/2010/091/000482
- 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 halobetasol or Clobetasol or salicylic acid or ointment base.
Immunocompromised 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 examinationTimepoint: Baseline and Days 8-10;CHANGES IN MEAN SCORE OF CLINICAL SIGNS AND SYMPTOMS AFTER THE TREATMENTTimepoint: Baseline, 4-6 days and 8-10 days;CHANGES IN MEAN TOTAL SCORE OF SIGNS/SYMPTOMS AFTER THE TREATMENTTimepoint: Baseline, 4-6 days and 8-10 days
- Secondary Outcome Measures
Name Time Method GLOBAL ASSESSMENT OF EFFICACY OF TREATMENT BY PHYSICIANS AND PATIENTS RESPECTIVELY<br>Timepoint: Day 8-10