A clinical Trial in-patients with Dermatomycoses.. Clinical trial is to study efficacy, safety and tolerability of Flutrimazole cream in comparison to Terbinafine Hydrochloride cream (reference product).

Phase 3

Completed

• Conditions: Other infectious disease,

• Registration Number: CTRI/2010/091/000141
• Lead Sponsor: Ajanta Pharma Ltd

Brief Summary

This study is a randomized, comparative, double blind and multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Flutrimazole 1% cream Vs Terbinafine Hydrochloride cream for 28 days in 200 patients with Dermatomycoses that will be conducted in three centers. Date of first enrollment will be 2 March, 2010. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

The primary outcome measures will be assessment by grading Ring-like lesion, Scaling, Erythema, Burning, Itching and Vesicles at day 0, Day 7, Day 14 and Day 28. Mycological assessment, Global assessment of treatment and safety and tolerability will be done as secondary outcome measures.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-03
• Last Update Posted: 2018-11-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Clinical diagnosis of Dermatomycoses confirmed by laboratory evaluation (microscopic examination confirmed by a positive potassium hydroxide test).
• Written informed consent by patient.
• Patient willing to follow up.

Exclusion Criteria

Pregnant or nursing females.2. Patients with severe chronic diseases.3. Individuals who present a history of hypersensitivity to other antifungal imidazolic, or any of the components of the pharmaceutical form used.4. 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
Ring-like lesion, Scaling, Erythema, Burning, Itching and Vesicles	Day 0, Day 7, Day 14 and Day 28.

Secondary Outcome Measures

Name	Time	Method
Global Assessment of treatment	Day 28
Mycological assessment	Day 0 and Day 28
Safety and Tolerability	Day 0, Day 7, Day 14 and Day 28.

Trial Locations

Locations (3)

Aarupadai Veedu Medical College & Hospital; 🇮🇳 Pondicherry, PONDICHERRY, India

Healthy Skin Clinic; 🇮🇳 Coimbatore, TAMIL NADU, India

Skin Care Center; 🇮🇳 Bangalore, KARNATAKA, India

Aarupadai Veedu Medical College & Hospital

🇮🇳Pondicherry, PONDICHERRY, India

Dr C Udayashankar

Principal investigator

09944122744

udayderm@yahoo.com