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CTRI Number  CTRI/2021/05/033812 [Registered on: 25/05/2021] Trial Registered Prospectively
Last Modified On: 19/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Topical ketoconazole 2% lotion vs topical oxiconazole nitrate 1% lotion for pityriasis versicolor 
Scientific Title of Study   A randomized double blind study comparing topical ketoconazole 2% lotion and topical oxiconazole nitrate 1% lotion in treatment of pityriasis versicolor 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sivakumar Sivasubramaniam 
Designation  Professor 
Affiliation  Vinayaka Missions Medical college 
Address  Department of Dermatology Venereology and Leprosy Vinayaka Missions Medical college Kezhakasakudymedu Karaikal
Department of Dermatology Venereology and Leprosy Vinayaka Missions Medical college Kezhakasakudymedu Karaikal
Pondicherry
PONDICHERRY
609609
India 
Phone  8072878732  
Fax    
Email  om.siva55@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sivakumar Sivasubramaniam 
Designation  Professor 
Affiliation  Vinayaka Missions Medical college 
Address  Department of Dermatology Venereology and Leprosy Vinayaka Missions Medical college Kezhakasakudymedu Karaikal
Department of Dermatology Venereology and Leprosy Vinayaka Missions Medical college Kezhakasakudymedu Karaikal
Pondicherry
PONDICHERRY
609609
India 
Phone  8072878732  
Fax    
Email  om.siva55@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sukanya Sivasubramaniam 
Designation  PG student 
Affiliation  Vinayaka Missions Medical college 
Address  Department of Dermatology Venereology and Leprosy Vinayaka Missions Medical college Kezhakasakudymedu Karaikal
Department of Dermatology Venereology and Leprosy Vinayaka Missions Medical college Kezhakasakudymedu Karaikal
Pondicherry
PONDICHERRY
609609
India 
Phone  9500622129  
Fax    
Email  sukanyasoumi@gmail.com  
 
Source of Monetary or Material Support  
Vinayaka Missions research foundation 
 
Primary Sponsor  
Name  Vinayaka Missions Medical college 
Address  Keezhakasakudymedu Karaikal 
Type of Sponsor  Private 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 
Sivakumar Sivasubramaniam  Vinayaka Missions Medical college  Department of Dermatology Venereology and Leprosy Karaikal PONDICHERRY
Karaikal
PONDICHERRY 		 8072878732

om.siva55@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B360||Pityriasis versicolor,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Topical ketoconazole 2% lotion in treatment of pityriasis versicolor  Patients with pityriasis versicolor was treated with topical ketoconazole 2% lotion once daily for 4 week 
Intervention  Topical oxiconazole nitrate 1% lotion in treatment of pityriasis versicolor   Patients with pityriasis versicolor was treated with topical oxiconazole nitrate 1% lotion once daily for 4 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Clinically and Mycologically diagnosed with Pityriasis versicolor
Both sexes
Patients belonging to age above 18 years
 
 
ExclusionCriteria 
Details  Patient who have diabetes, malignancy, HIV, under steroids/immunosuppressive drugs and other known immunocompromised states
Patients with history of adverse response to imidazole derivatives or to any component of the formulation
Patient who received any kind of anti fungal treatment in last 3 months
Pregnant women
Severely ill patients
Non – compliant patients

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Compare the clinical responses by global assessment to ketoconazole lotion and oxiconazole nitrate lotion
 		 At end of first week, fourth week and 3 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Relapse rate of disease   At end of 3 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/06/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   After obtaining informed written consent, 60 patients of pityriasis versicolor will be recruited for the study after applying inclusion criteria(clinically and mycologically diagnosed with pityriasis versicolor, both sexes, age above 18 years) and exclusion criteria(patient who have diabetes, malignancy, HIV, under steroids/ immunosuppressive drugs and other known immunocompromised states, patients with history of adverse response to imidazole derivatives or to any component of the formulation, patient who received any kind of anti fungal treatment in last 3 months, pregnant women, severely ill patients, non – compliant patients).
They will be randomized into two groups of 30 each, one group treated with topical ketoconazole 2% lotion once daily for 4 weeks and other group treated with topical oxiconazole nitrate 1% lotion once daily for 4 weeks.
Patient follow up to be done at end of first week , fourth week and 3 months. During each visit, clinical response is graded as cleared, excellent, good, fair, poor, worse. A close watch on any adverse effects of the drugs to be during each visit and relapse rate of disease at end of 3 weeks monitored and documented. 
 
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