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).

Phase 3

Completed

• Conditions: Disorder of the skin and subcutaneous tissue, unspecified, Tinea pedis and Tinea cruris infection,

• Registration Number: CTRI/2009/091/001025
• Lead Sponsor: Ajanta Pharma Limited

Brief Summary

This study is a comparative, Randomized, Double Blind, Multicentric, Prospective Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Naftifine Hydrochloride 1% cream Vs Terbinafine Hydrochloride 1% cream (Reference Drug), in 200 patients with Tinea pedis and Tinea cruris. Date of enrollment is 04 Jan 2010. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

 The primary outcome measures are change in clinical efficacy parameters i.e. itching, erythema, scaling/crusting, vesicles and papules etc. by four point scales on day 0, 7, 14 and 28. Secondary out come measure is patients and physicians Global Assessment of treatment efficacy and tolerability at 28th day and overall response by mycological assessment (KOH mount) at day 0 and day 28.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-01
• Last Update Posted: 2018-11-22

Recruitment & Eligibility

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

Inclusion Criteria

• Males and female patients with age 18 to 70 years.
• Clinical diagnosis of Tinea pedis and Tinea cruris 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 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
Itching, Erythema, Scaling/Crusting, Vesicles and papules	Day 0, Day 7,Day 14 and Day 28.

Secondary Outcome Measures

Name	Time	Method
Patients and physicians Global Assessment of treatment efficacy and tolerability	Day 28
Overall response by mycological assessment (KOH mount)	Day 0 and Day 28

Trial Locations

Locations (4)

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

Bharathi Rajaa Speciality Hospital & Research Centre; 🇮🇳 Chennai, TAMIL NADU, India

Keshav Skin and Hair Clinic; 🇮🇳 Aurangabad, BIHAR, India

Sai Lee Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Aarupadai Veedu Medical College & Hospital

🇮🇳Pondicherry, PONDICHERRY, India

Dr C Udayashankar

Principal investigator

09944122744

udayadarma@yahoo.com