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CTRI Number  CTRI/2018/06/014630 [Registered on: 28/06/2018] Trial Registered Prospectively
Last Modified On: 21/06/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To zoom in and look for minute features of superficial fungal infection  
Scientific Title of Study   Dermoscopy- a useful tool for diagnosis 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  Dr Malcom Noronha  
Designation  Junior Resident 
Affiliation  Manipal Academy of Higher Education (MAHE) 
Address  Room no. 21, Old Opd Building , Manipal, Udupi. 576104

Udupi
KARNATAKA
576104
India 
Phone  9008839790  
Fax    
Email  malcom.nornoha@live.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Malcom Noronha  
Designation  Junior Resident 
Affiliation  Manipal Academy of Higher Education (MAHE) 
Address  Room no. 21, Old Opd Building , Manipal, Udupi. 576104

Udupi
KARNATAKA
576104
India 
Phone  9008839790  
Fax    
Email  malcom.nornoha@live.com  
 
Details of Contact Person
Public Query
 
Name  Dr Malcom Noronha  
Designation  Junior Resident 
Affiliation  Manipal Academy of Higher Education (MAHE) 
Address  Room no. 21, Old Opd Building , Manipal, Udupi. 576104

Udupi
KARNATAKA
576104
India 
Phone  9008839790  
Fax    
Email  malcom.nornoha@live.com  
 
Source of Monetary or Material Support  
Kasturba Medical College and kasturba hospital, Room no. 21, Old Opd Building , Manipal, Udupi.  
 
Primary Sponsor  
Name  Kasturba Medical College 
Address  Kasturba Medical College, Kasturba Hospital, Madhav Nagar, Manipal, 576104  
Type of Sponsor  Research institution and hospital 
 
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 Malcom Noronha   Kasturba Medical College, Manipal  Department of Dermatology, Room no. 22, 2nd floor
Udupi
KARNATAKA 
9008839790

malcom.noronha@live.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pityriasis Versicolor 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients suffering from Pityriasis Versicolor and ready to cooperate for study 
 
ExclusionCriteria 
Details  If patient does not give consent  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
It will help in diagnosing Pityriasis Versicolor using a non-invasive technique (dermoscopy)  6 months  
 
Secondary Outcome  
Outcome  TimePoints 
dermoscopic features of pityriasis versicolor   6 months  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   29/06/2018 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Pityriasis versicolor is a superficial fungal infection of the skin. It is caused by Malassezia, a lipophilic dimorphic fungus. This fungus is part of the normal skin flora but can cause disease when it converts to its pathogenic hyphal form. Certain genetics and environmental factors play a role in the same. Clinically, these patients present with varied color patches which are usually covered with fine scales in seborrehic area distribution. Close differential diagnosis of tinea versicolor is confluent and reticulated papillomatosis , seborrheic dermatitis, erythrasma. Treatment line of all these conditions is different from pityriasis versicolor, hence differentiation is required. Scales over the lesions are very fine, making it difficult to examine with naked eyes, hence scraping and biopsy is usually used for confirmation of the diagnosis. Scraping of the lesions yields scales which can be mounted on microscope and fungal elements if present can be appreciated. But for confirmation biopsy with PAS stain is to be done which shows characteristic, “spaghetti and meatball” appearance.

Dermoscopy is a non-invasive tool which shows submacroscopic features of various dermatoses. It has been traditionally used in the diagnosis of melanoma is Western population. Use of dermoscopy in general dermatology practice is recently being employed. There is only one case report regarding dermoscopic features of versicolor in literature. No study has yet been published illustrating the dermoscopic features of various types of tinea versicolor. Hence, we want to carry out this study to look for a non-invasive technique to diagnose versicolor which can be done by the physician himself, bedside, within a span of few minutes.

 

References –

1.       Pedrosa AF, Lisboa C, Goncalves RA. Malassezia infections: a medical conundrum. J Am Acad Dermatol. 2014;71:170-176.

2.       Renati S, Cukras A, Bigby M. Pityriasis versicolor. BMJ. 2015;350: 1394.



 
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