A clinical trial to study the effect of a fixed dose formulation of Sertaconazole + Beclomethasone and miconazole nitrate in patients with tinea infections associated with inflammatory skin conditions.
- Registration Number
- CTRI/2010/091/000178
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
Male & female (post-menopausal, surgically sterilized or practicing a reliable method of birth control) patients with age ranging from 18 to 70 years;Clinical diagnosis of tinea infections, confirmed by laboratory evaluation (microscopic examination confirmed by a positive potassium hydroxide [KOH] test) with inflammatory dermatoses;Written informed consent by patient; Patient willing to follow up.
Pregnant or lactating women;Patients who had received oral treatment with antimycotics during the 4 weeks preceding the trial or topical treatment during the week before; Patients with compromised immunity (patients taking steroid, immunosuppresants or with HIV/AIDS;Applied topical antifungal therapy to the feet within 14 days of study or had been treated with oral antifungal therapies within 3 months of study entry;Hypersensitivity to Sertaconazole nitrate, beclomethasone dipropionate, miconazole or base of cream; 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 Clinical evaluation of the disease assessed in accordance with the clinical scale; Mycologic assessment;PhysicianTimepoint: Baseline, Days 7, 14 and 28
- Secondary Outcome Measures
Name Time Method Global assessment of clinical response; Overall response at 4 weekTimepoint: End of study