A clinical trial to study the effects of two drugs, naftifine and terbinafine in patients with dermatophytosis.

Phase 3

Completed

• Registration Number: CTRI/2009/091/000679
• Lead Sponsor: Sun Pharmaceutical Industries Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Male or female patients aged between 18 and 65 years.
2.Patients with a clinical diagnosis of dermatophytosis.
3.Patient willing to give their informed consent.

Exclusion Criteria

1.Pregnant or lactating women and women of childbearing potential who are not on an acceptable birth control methods.
2.Patients with any systemic condition predisposing them to fungal infection or with any skin disease that might interfere with the study.
3.Patients using topical antifungals, topical corticosteroids, or systemic antibacterials before 14 days of study entry.
4.Patients using systemic antifungals or corticosteroids before 4 weeks of the study entry.
5.Patients using other concomitant systemic or topical therapy with antibiotics, antimycotics or corticosteroids.
6.Patients having hypersensitivity with Naftifine or Terbinafine.
7.Patients having a serum creatinine of > 1.5 x upper limit of normal.
8.Patients having history of alcohol, narcotic or drug abuse.
9.Patients with severe renal and hepatic impairment.
10.Patients having thyroid stimulating hormone value outside the normal range.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of following symptoms using 4 point Visual Analogue Scale (VAS). <br>1.Percentage of patients with erythema.<br>2.Percentage of patients with pruritus.<br>3.Percentage of patients with maceration.<br>4.Percentage of patients with fissuring.<br>5.Percentage of patients with scaling.<br>Timepoint: Baseline (Day 0), week 2 and week 4.

Secondary Outcome Measures

Name	Time	Method
1.Average change from baseline in Clinical Global Impression on Severity (CGI-S) in patients by investigator.<br>2.Clinical Global Impression on Improvement (CGI-I) in patients by investigator.Timepoint: 1.Baseline (day 0) and week 4<br>2.Week 2 and week 4<br>