Health Condition 1: null- Patients With Tinea Infections
Conditions
Interventions
Intervention1: Ketoconazole 2 % in Combination With Beclomethasone 0.025%: once daily to cover the affected and immediate surrounding area.
Control Intervention1: Not applicable: Not applicable
Sponsors
Med Manor Organics Pvt ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacyof ketoconazole 2 % in combination with Beclomethasone 0.025% ointment in preventing the Tinea InfectionsTimepoint: 2 Weeks form base line | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 2 weeks study follow up 2 weeks Telephonic follow up | — |
Countries
India
Contacts
Public ContactMr Pavan Suman
Med Manor Organics Pvt ltd
Outcome results
None listed