| CTRI Number |
CTRI/2020/10/028369 [Registered on: 13/10/2020] Trial Registered Prospectively |
| Last Modified On: |
09/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Dermoscopic test for confirming the diagnosis of tinea versicolor. |
|
Scientific Title of Study
|
Dermoscopic findings in cases 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 |
DrAshka Shah |
| Designation |
1st year resident |
| Affiliation |
GMERS medical college and hospital, Gotri. |
| Address |
205- skin opd GMERS hospital Gotri Vadodara
302-B meridian prime next to ward-11 office diwalipura vadodara.
Vadodara
GUJARAT
390012
India |
| Phone |
9825034452 |
| Fax |
|
| Email |
ashkashah93@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sejal Thakkar |
| Designation |
Associate professor |
| Affiliation |
GMERS medical college and hospital, Gotri. |
| Address |
205- skin opd GMERS hospital Gotri Vadodara
202, wings ville 41, arunday society, alkapuri, vadodara
Vadodara
GUJARAT
390012
India |
| Phone |
9824097310 |
| Fax |
|
| Email |
drsejal98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAshka Shah |
| Designation |
1st year resident |
| Affiliation |
GMERS medical college and hospital, Gotri. |
| Address |
205- skin opd GMERS hospital Gotri Vadodara
302-B meridian prime next to ward-11 office diwalipura vadodara.
Vadodara
GUJARAT
390012
India |
| Phone |
9825034452 |
| Fax |
|
| Email |
ashkashah93@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Ashka shah |
| Address |
501-B shubham appt., near noopur hospital, city light, surat |
| Type of Sponsor |
Other [self] |
|
|
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 Ashka shah |
GMERS Medical college and hospital |
205- skin OPD, GMERS medical college and hospital, Gotri, Vadodara
Vadodara
GUJARAT |
9825034452
ashkashah93@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional human ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed cases of P.Versicolor-
of either sex and all age groups will be included.
willing to allow KOH scrapping to be taken.
willing to allow dermoscopy to be performed.
patients willing to take part in the study. |
|
| ExclusionCriteria |
| Details |
patients who underwent systemic treatment in the past 6 months or topical treatment in the past 1 month for P.versicolor.
patient denying photographic consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| conclusive data regarding dermoscopic findings of P.versicolor. |
at 6 months and 11 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
ease of diagnosis in future.
can stamp diagnosis of P.versicolor. |
at 6 months and 11 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
16/10/2020 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Clinically diagnosed cases of P.versicolor of either sex and all age groups will be included. Dermoscopy is an futuristic diagnostic tool, which will help in diagnosis of pityriasis versicolor and other skin diseases in future. |