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CTRI Number  CTRI/2018/04/012971 [Registered on: 03/04/2018] Trial Registered Retrospectively
Last Modified On: 02/04/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of sertaconazole, eberconazole and miconazole creams in treatment of ringworm infection. 
Scientific Title of Study   Randomized controlled trial of topical sertaconazole and eberconazole in comparison to topical miconazole in localized dermatophyte infection 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IPGME&R / Pharma / 2015 / CT-01  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prajesh Kiran Bhunya 
Designation  Resident 
Affiliation  IPGMER Kolkata 
Address  Department of Pharmacology IPGMER 244 AJC Bose Road Kolkata

Kolkata
WEST BENGAL
700020
India 
Phone  7431806060  
Fax    
Email  pkbsmch014@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prajesh Kiran Bhunya 
Designation  Resident 
Affiliation  IPGMER Kolkata 
Address  Department of Pharmacology IPGMER 244 AJC Bose Road Kolkata


WEST BENGAL
700020
India 
Phone  7431806060  
Fax    
Email  pkbsmch014@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Avijit Hazra 
Designation  Professor 
Affiliation  IPGMER Kolkata 
Address  Department of Pharmacology IPGMER 244 AJC Bose Road Kolkata

Kolkata
WEST BENGAL
700020
India 
Phone  9831188172  
Fax    
Email  blowfans@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Pharmacology IPGMER Kolkata 
 
Primary Sponsor  
Name  Department of Pharmacology  
Address  IPGMER 244 AJC Bose Road, Kolkata 700020. 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prajesh Kiran Bhunya  IPGMER  OPD, Department of Dermatology 244 AJC Bose Road Kolkata 700020
Kolkata
WEST BENGAL 
7431806060

pkbsmch014@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGMER Research Oversight Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Tinea (dermatophytosis) excluding hair and nails,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Eberconazole  Topical eberconazole nitrate 1% (w/w in cream base) applied twice daily for 4 weeks. 
Comparator Agent  Miconazole  Topical miconazole nitrate 2% ( w/w in cream base) applied twice daily for 4 weeks. 
Intervention  Sertaconazole  Topical sertaconazole nitrate 2% ( w/w in cream base) applied twice daily for 4 weeks. 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients suffering from dermatophyte infection in the form of localized tinea lesions such as tinea corporis and tinea cruris.
2. Willing to provide written informed consent.
 
 
ExclusionCriteria 
Details  1. Female patients who are pregnant or breast feeding.
2. Patients with disseminated tinea infection.
Patients with uncontrolled diabetes mellitus or severely immunocompromising disorders like HIV/AIDS.
3. Patients with serious disease of vital organs like heart, lungs, liver, kidney or bone marrow.
4. Patients suffering from alcoholism, other substance abuse disorders or active psychiatric disorders.
5. Patients with history of hypersensitivity to systemic or topical formulations of azole antifungals including miconazole, sertaconazole or eberconazole.
6. Participation in another clinical trial within last 30 days.
7. Any other condition, which in the opinion of the principal investigator, will prevent the subject from complying with visit schedules and instructions.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical cure at 4 weeks – implying resolution of the lesion and associated symptoms.  Baseline 2 weeks 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical cure at 2 weeks.  2 weeks 
Changes in Total Symptom Score (TSS) based on erythema, scaling, and pruritus scores.  Baseline 2 weeks 4 weeks 
Overall response at 4 weeks based on 6 point global response scale.  4 weeks 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
Final Enrollment numbers achieved (Total)= "206"
Final Enrollment numbers achieved (India)="206" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   29/12/2015 
Date of Study Completion (India) 29/06/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet published. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Skin is a protective barrier also has cosmetic value. Dermatophyte infection is commonest superficial fungal infection in the world which affect skin, hair nail. It is more prevalent in tropical countries like India. Dermatophyte infection can cause significant morbidity. Working days may be lost and social life may be affected. Several environmental, social and immunological factors contributes to the disease. Disease like diabetes malignancy HIV/AIDS  which decreases immunity and immunosuppressive drugs, steroid use prolongs disease. For the treatment of superficial fungal diseases topical antifungal agents are used. Imidiazole group antifungal miconazole is a common drugs used in this purpose. Newer imidiazole antifungals like sertaconazole and eberconazole claims to have better efficacy than miconazole as they have additional anti-inflammatory property. The imidiazole group of antifungal drugs attains significant amount of concentration in superficial layers of skin. Drug level in deeper layer and systemic absorption is negligible. They penetrate horny layer of skin and remains there for long time, so their use in superficial fungal infection is preffered.

 

The objective of the study was to carry out a head-to-head comparison of the newer imidazoles, topical sertaconazole and topical eberconazole, with the established topical antifungal miconazole in the management of cutaneous dermatophyte infection with respect to both effectiveness and safety.

 

Over a recruitment period of 12 months 206 patients who gave consent were randomized to three study arms. First follow up visit was at 2 weeks and end of study visit was at 4 weeks. Overall, 69 patients on miconazole, 62 on sertaconazole and 68 on eberconazole completed the study.

 

Baseline characteristics of all three groups were comparable. We looked for decrease in erythema, pruritus, scaling and total symptom score. These parameters decreased significantly from base line to 2nd week follow-up and to study end in each of the three study groups, with no significant intergroup differences at any time point. Complete clinical cure (that is resolution of lesion with all associated symptoms) in miconazole, sertaconazole, eberconazole group was 46.38%, 46.77% and 58.82% respectively. This difference was not significant statistically. However, clinical cure rate at 2 weeks was 3.23% and 16.18% in sertaconazole and eberconazole group respectively (p = 0.018) without any such case in the miconazole. Compliance, assessed with the help of a medication adherence record sheet, was good to excellent in most study subjects. No clinically significant adverse drug reactions were noted in any study arm.

 

Therefore, in conclusion, despite an early trend favoring eberconazole, clinical cure at 4 weeks was comparable with the older drug miconazole. Clinical cure was not achieved in approximately 50% of the subjects at 4 weeks. Tolerability of all three preparations was excellent.


 
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