A comparative study between Whitfields ointment + Oral fluconazole Vs 1% butenafine in tinea infections of skin

Not Applicable

Completed

• Conditions: Tinea infections of skin

• Registration Number: CTRI/2012/08/002914
• Lead Sponsor: Department of Pharmacology and Department of Skin and VD CU Shah Medical College and Hospital

Brief Summary

Thisstudy is a randomized, open label  parallelgroup, trial comparing the efficacy, safety and cost effectiveness betweenWhitfield’s ointment + Oral Fluconazole vs. 1% butenafine in tinea infectionsof skin. The primary outcome measures were the efficacy a. Efficacy (1. Changein baseline sign and symptoms score 2. Change in Physician’s Global EvaluationResponse b. Safety (No. of ADRs developed & percentage of the participantsdeveloping ADRs) c. Cost effectiveness (Incremental cost and Incrementaleffectiveness) over one month. The secondary outcomes were1) Assessment ofclinico mycological correlation2)Comparison of relapse rate with both thetreatments 3)To identify and find the prevalence of different species of tinea

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-05
• Last Update Posted: 2012-04-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

New patients attending skin O.P.D.

Exclusion Criteria

1. Follow up cases 2) pregnant or lactating women, 3) patients having allergy to topical imidazole or any other antifungals used in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change in baseline sign and symptoms score	one month
2. Change in Physician’s Global Evaluation Response	one month
b. Safety (No. of ADRs developed & percentage of the participants developing ADRs)	one month
c. Cost effectiveness (Incremental cost and Incremental effectiveness)	one month

Secondary Outcome Measures

Name	Time	Method
1. Assessment of clinico mycological correlation	2.Comparison of relapse rate with both the treatments

Trial Locations

Locations (1)

Department of Pharmacology and Dermatology; 🇮🇳 Surendranagar, GUJARAT, India

Department of Pharmacology and Dermatology

🇮🇳Surendranagar, GUJARAT, India

Saket J Thaker

Principal investigator

09820599985

saketthaker@gmail.com