| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pityriasis Versicolor |
|
|
Intervention / Comparator Agent
|
|
|
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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