Main
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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:
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CTRI |
Last refreshed on:
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24 November 2021 |
Main ID: |
CTRI/2014/12/005246 |
Date of registration:
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03-12-2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Comparison of safety and efficacy of two antifungal creams amorolfine and sertaconazole in treatment of superficial fungal infection (Tinea)
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Scientific title:
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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:
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02-05-2014 |
Target sample size:
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66 |
Recruitment status: |
Open to Recruitment |
URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9508 |
Study type:
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Interventional |
Study design:
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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
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Phase:
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Phase 4
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Countries of recruitment
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India
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Contacts
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Name:
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Nilay Kanti Das
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Address:
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Department of Dermatology
Medical College
88 College Street
Kolkata 73
700073
Gandhinagar, WEST BENGAL
India |
Telephone:
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9433394148 |
Email:
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drdasnilay@gmail.com |
Affiliation:
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Medical College Kolkata |
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Name:
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Amrita Sil
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Address:
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Department of Pharmacology
IPGME & R
244 AJC Bose Road
Kolkata 20
700073
Kolkata, WEST BENGAL
India |
Telephone:
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9433394148 |
Email:
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drdasnilay@gmail.com |
Affiliation:
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Medical College Kolkata |
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Key inclusion & exclusion criteria
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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:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- Tinea cruris / corporis limited variety
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Intervention(s)
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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
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Primary Outcome(s)
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Clinical cureTimepoint: 2nd week,4th week and 6th week
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Secondary Outcome(s)
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Quality of life judged by DLQI (Dermatology life Quality Index) questionnaireTimepoint: 2nd week, 4th week, 6th week
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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
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Spontaneously reported adverse events and those elicited by the clinicianTimepoint: 2nd week, 4th week, 6th week
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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
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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
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Mycological cure (defined as negative KOH microscopy and negative culture)Timepoint: 4th week and 6th week
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Routine laboratory investigations: Routine hemogram, random blood sugar, urea, creatinine, liver function tests (LFT).Timepoint: At baseline and week 4 visit
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Source(s) of Monetary Support
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Institutional Medical College Kolkata
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Ethics review
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Status: Approved
Approval date: 26/04/2014
Contact:
Institutional Ethics Committee for Human Research, Medical College, Kolkata
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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