A clinical Trial in patients with Tinea pedis and Tinea cruris. Clinical trial is to study efficacy, safety and tolerability of Naftifine Hydrochloride 1% cream in comparison to Terbinafine Hydrochloride 1% cream (reference product).
- Conditions
- Health Condition 1: L989- Disorder of the skin and subcutaneous tissue, unspecifiedHealth Condition 2: null- Tinea pedis and Tinea cruris infection
- Registration Number
- CTRI/2009/091/001025
- Lead Sponsor
- Ajanta Pharma Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
1. Males and female patients with age 18 to 70 years.
2. Clinical diagnosis of Tinea pedis and Tinea cruris confirmed by laboratory evaluation (microscopic examination confirmed by a positive potassium hydroxide test).
3. Written informed consent by patient.
4. Patient willing to follow up.
1. Pregnant or nursing females.
2. Patients suffering from onchomycosis, candidiasis, pityriasis versicolor or tinea capitis.
3. Patients with severe chronic diseases.
4. Hypersensitivity to components of Niftifine such as benzyl alcohol,cetyl alcohol ,cetyl esters wax,isopropyl myristate,polysorbat 60,sodium hydroxide,sorbitan monostearate etc.
5. Patients who might have required concomitant medication with other antimycotics administered by another route.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method