Safety and efficacy of Ketoconazole in Combination With Beclomethasone

Not Applicable

Completed

Conditions: Patients With Tinea Infections

Registration Number: CTRI/2018/02/011935

Lead Sponsor: Med Manor Organics Pvt ltd

Brief Summary: This study is an Open Label, Single arm, Observational Study to Evaluate the Efficacy, Safety & Tolerability of Ketoconazole 2 % in Combination With Beclomethasone 0.025% in (**Keto B ointment)** Patients With Tinea Infections for evaluation of the safety, efficacy and tolerability of 4Ketoconazole 2 % in combination with Beclomethasone 0.025% in patients with Dermatophytoses (Fungal Infection)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 50

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

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 Infections	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 patient	total 4 week

Trial Locations

Locations (1): Dr. B.R. Ambedkar Medical College
🇮🇳
Bangalore, KARNATAKA, India
Dr. B.R. Ambedkar Medical College
🇮🇳Bangalore, KARNATAKA, India
Dr Madan Mohan NT
Principal investigator
9845074316
madanmohan1869@gmail.com