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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: CTRI
Last refreshed on: 24 November 2021
Main ID:  CTRI/2014/12/005246
Date of registration: 03-12-2014
Prospective Registration: No
Primary sponsor: Medical College Kolkata
Public title: Comparison of safety and efficacy of two antifungal creams amorolfine and sertaconazole in treatment of superficial fungal infection (Tinea)
Scientific title: A randomized, double-blind, controlled trial of amorolfine 0.25% cream versus sertaconazole 2% cream in limited variety of tinea cruris/ corporis. - TINEAAMSER
Date of first enrolment: 02-05-2014
Target sample size: 66
Recruitment status: Open to Recruitment
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9508
Study type:  Interventional
Study design:  Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
 
Phase:  Phase 4
Countries of recruitment
India
Contacts
Name: Nilay Kanti Das   
Address:  Department of Dermatology Medical College 88 College Street Kolkata 73 700073 Gandhinagar, WEST BENGAL India
Telephone: 9433394148
Email: drdasnilay@gmail.com
Affiliation:  Medical College Kolkata
Name: Amrita Sil   
Address:  Department of Pharmacology IPGME & R 244 AJC Bose Road Kolkata 20 700073 Kolkata, WEST BENGAL India
Telephone: 9433394148
Email: drdasnilay@gmail.com
Affiliation:  Medical College Kolkata
Key inclusion & exclusion criteria
Inclusion criteria: •Untreated male and non-¬pregnant female patients above 18 years of age

•Acute, symptomatic tinea cruris/corporis with limited involvement i.e. limited to single body region

•KOH mount showing positive results (hyphae)


Exclusion criteria: •Pregnant or nursing females

•Patients with diabetes mellitus, malignancy, renal or hepatic dysfunction

•Patients who received topical antifungal agents within the past week or received systemic antifungal agents within past four weeks.

•History of hypersensitivity to any of the study drugs

•Patients not willing to comply with protocol requirements



Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Health Condition 1: null- Tinea cruris / corporis limited variety
Intervention(s)
Intervention1: Amorolfine 0.25% cream: Amorolfine 0.25% cream applied locally over lesion for 4 weeks twice daily
Control Intervention1: Sertaconazole 1% cream: Sertaconazole 1% cream applied locally over lesion for 4 weeks twice daily
Primary Outcome(s)
Clinical cureTimepoint: 2nd week,4th week and 6th week
Secondary Outcome(s)
Quality of life judged by DLQI (Dermatology life Quality Index) questionnaireTimepoint: 2nd week, 4th week, 6th week
Global cure (combined mycological and clinical cure). Patients will be classified as cured for this combined variable only if they are mycologically and clinically clear. All other cases will be classified as failures for this particular variableTimepoint: 4th week and 6th week
Spontaneously reported adverse events and those elicited by the clinicianTimepoint: 2nd week, 4th week, 6th week
Gradation of the Clinical improvement as follows:

o Grade 0 (Clinical Failure): No improvement.

o Grade I: Persistence of few papular lesions or erythema with mild to moderate itching.

o Grade II: Scaly lesions with or without itching.

o Grade III (Clinical cure): Disappearance of original lesions with or without residual pigmentationTimepoint: 4th week and 6th week
Global assessment of safety and efficacy

At the end of treatment and test of cure, patients as well as the investigator will assess treatment for safety as well as efficacy on the Likertâ??s five point scale as- poor, fair, good, very good, excellent.Timepoint: 4th week and 6th week
Mycological cure (defined as negative KOH microscopy and negative culture)Timepoint: 4th week and 6th week
Routine laboratory investigations: Routine hemogram, random blood sugar, urea, creatinine, liver function tests (LFT).Timepoint: At baseline and week 4 visit
Secondary ID(s)
NIL
Source(s) of Monetary Support
Institutional Medical College Kolkata
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 26/04/2014
Contact:
Institutional Ethics Committee for Human Research, Medical College, Kolkata
Results
Results available:
Date Posted:
Date Completed:
URL:
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