| CTRI Number |
CTRI/2020/10/028284 [Registered on: 08/10/2020] Trial Registered Prospectively |
| Last Modified On: |
07/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of infectious and noninfectious granulomas through dermoscope |
|
Scientific Title of Study
|
Dermoscopic study of granulomatous dermatoses |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hita H Mehta |
| Designation |
Professor and head, department of dermatology, gmc bhavnagar |
| Affiliation |
Governmwnt medical.college bhavnagar |
| Address |
Opd 115, skin opd, first floor,sir t hospital, gmc, bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9429503188 |
| Fax |
|
| Email |
hitamehta88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hita H Mehta |
| Designation |
Professor and head, department of dermatology, gmc bhavnagar |
| Affiliation |
Government medical.college bhavnagar |
| Address |
Opd 115, skin opd, first floor,sir t hospital, gmc, bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9429503188 |
| Fax |
|
| Email |
hitamehta88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hita H Mehta |
| Designation |
Professor and head, department of dermatology, gmc bhavnagar |
| Affiliation |
Governmwnt medical.college bhavnagar |
| Address |
Opd 115, skin opd, first floor, sir t hospital, gmc,bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9429503188 |
| Fax |
|
| Email |
hitamehta88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of.dermatology,Sir T thospital, GMC bhavnagar |
|
|
Primary Sponsor
|
| Name |
Department of Dermatology gmc bhavnagar |
| Address |
Opd 115, first floor, sir t hospital,gmc,bhavnagar |
| Type of Sponsor |
Government medical college |
|
|
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 Hita H Mehta |
Sir t hospital, GMC bhavnagar |
Opd 115 first floor sir t hospital , kala nala
Bhavnagar
GUJARAT |
9429503188
hitamehta88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board (bhavanagr) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L929||Granulomatous disorder of the skinand subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All age groups
Both gender
Patients having CGDs
Giving consent for dermoscopy pictures
Maximum 2 lesions from a single patient
|
|
| ExclusionCriteria |
| Details |
Skin diseases with pus discharge and ulcerations will be excluded.
Patient who refuse to give consent for clinical photographs will also be excluded |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dermoscopic pattern of different granulomatous diseases |
At time of first visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/10/2020 |
| 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="0"
Days="0" |
|
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
|
A dermoscope is a rapid, non-invasive diagnostic tool which visualizes subsurface skin structures which can not be seen with naked eyes.•Recently, dermatoscopy has been demonstrated to be a useful tool for assisting the recognition of several GDs.Classical yellowish orange patches in dermoscopy are diagnostic clue in most of the granulomatous disorders . As granulomatous disorders have multiple etiology, other DS features can be helpful for differentiation. Thus with dermoscopy we could diagnose cases in early stage.
|