| CTRI Number |
CTRI/2024/03/064139 [Registered on: 14/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Surface microscopy in Leprosy |
|
Scientific Title of Study
|
Clinicodermoscopy and Histopathological Associations in various poles of Hansens disease:A cross sectional study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Debadeepta Dey |
| Designation |
PG Resident Dermatology |
| Affiliation |
IMS and Sum Hospital |
| Address |
Post graduate room,Department of SKIN &VD, IMS and Sum Hospital, K8 Kalinga Nagar, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
6371191053 |
| Fax |
|
| Email |
deydebadeepta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.AJAYA KUMAR JENA |
| Designation |
PROFESSOR |
| Affiliation |
IMS and Sum Hospital |
| Address |
Professor room,Department of SKIN & VD,IMS and Sum Hospital, K8, Kalinga Nagar, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
9437218952 |
| Fax |
|
| Email |
ajayajena@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Debadeepta Dey |
| Designation |
PG Resident Dermatology |
| Affiliation |
IMS and Sum Hospital |
| Address |
Department of SKIN & VD,IMS and Sum Hospital, K8 Kalinga Nagar, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
6371191053 |
| Fax |
|
| Email |
deydebadeepta@gmail.com |
|
|
Source of Monetary or Material Support
|
| IMS & SUM HOSPITAL,K8 Kalinga Nagar,Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Debadeepta Dey |
Bhubaneswar |
Bhubaneswar
Khordha
ORISSA |
6371191053
deydebadeepta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A309||Leprosy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients above 18years of both sexes clinically suspected of Hansens disease attending the SkIN & VD OPD & Patient who will give consent for biopsy & dermoscopy. |
|
| ExclusionCriteria |
| Details |
Patient who had already taken MDT in the past.
Patient who are not willing for biopsy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate whether dermoscopic features associates with the established histopathological findings in various poles of hansens disease |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/04/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patient consent will be taken for clinical photographs,dermoscopy & histopathological examination.Dermoscopic evaluation of suspected lesion(more active part) will be taken using a hand held dermlite-II hybrid M dermoscope at 10X magnification in polarised contact mode & photographs will be captured by apple I phone 12 with aid of dermlite app. Both polarised & nonpolarised mode will be used.The same site of the same lesion will also be biopsised & sent for histopathological examination. |