Safety and efficacy of Ketoconazole in Combination With Beclomethasone
- Conditions
- Health Condition 1: null- Patients With Tinea Infections
- Registration Number
- CTRI/2018/02/011935
- Lead Sponsor
- Med Manor Organics Pvt ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1.Subjects with tinea infections who are either treatment naive or were not on any treatment for at-least 3 months
2.Have a clinical diagnosis of uncomplicated interdigital Tinea pedis confirmed by KOH microscopy
3.Subjects aged 12 to 75 years with Tinea Infections
4.Subjects with Epidermal type of Tinea infections
5.Subjects willing to return for all clinic visits and complete all study-related procedures
1.Subjects with dermal or any other type of fungal infections other than epidermal type
2.Subjects who are either pregnant or breast feeding
3.Have a previous sensitivity to imidazole antifungal agents or to any ingredient of the study medication
4.Subjects taking any other form of alternative treatment like ayurvedic etc.. for fungal infections
5.Subjects known to have hypersensitivity to any of the ingredients of the formulation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacyof ketoconazole 2 % in combination with Beclomethasone 0.025% ointment in preventing the Tinea InfectionsTimepoint: 2 Weeks form base line
- Secondary Outcome Measures
Name Time Method To evaluate the safety and tolerability of ketoconazole 2 % in combinaton with Beclomethasone 0.025% cream based on the adverse effects as mentioned by the patientTimepoint: total 4 week <br/ ><br> <br/ ><br>2 weeks study follow up <br/ ><br>2 weeks Telephonic follow up