| CTRI Number |
CTRI/2022/09/045503 [Registered on: 14/09/2022] Trial Registered Prospectively |
| Last Modified On: |
13/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
USE OF DERMOSCOPY IN PIGMENTARY DISORDERS |
|
Scientific Title of Study
|
CORRELATION OF CLINICO-HISTOPATHOLOGICAL AND DERMOSCOPIC FINDINGS IN ACQUIRED DERMAL MACULAR HYPERPIGMENTATION IN A TERTIARY CARE HOSPITAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MV SAI GOUTHAM REDDY |
| Designation |
POST GRADUATE |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANGALORE |
| Address |
DEPTARTMENT OF DVL,
ROOM NO:10, FIRST FLOOR
KMC ATTAVAR HOSPITAL,
KASTURBA MEDICAL COLLEGE,
ATTAVAR,
MANGALORE.
KASTURBA MEDICAL COLLEGE,
LIGHTHOUSE HILL ROAD, HAMPANKATTA,
MANGALORE.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8019922557 |
| Fax |
|
| Email |
gouthamreddy.vr46@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
GATHA M UPADYA |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT OF DERMATOLOGY |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANGALORE |
| Address |
DEPTARTMENT OF DVL,
ROOM NO:10, FIRST FLOOR
KMC ATTAVAR HOSPITAL,
KASTURBA MEDICAL COLLEGE,
ATTAVAR,
MANGALORE.
KASTURBA MEDICAL COLLEGE,
LIGHTHOUSE HILL ROAD, HAMPANKATTA,
MANGALORE.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9845314028 |
| Fax |
|
| Email |
gatha.upadya@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
MV SAI GOUTHAM REDDY |
| Designation |
POST GRADUATE |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANGALORE |
| Address |
DEPTARTMENT OF DVL,
ROOM NO:10, FIRST FLOOR
KMC ATTAVAR HOSPITAL,
KASTURBA MEDICAL COLLEGE,
ATTAVAR,
MANGALORE.
KASTURBA MEDICAL COLLEGE,
LIGHTHOUSE HILL ROAD, HAMPANKATTA,
MANGALORE.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8019922557 |
| Fax |
|
| Email |
gouthamreddy.vr46@gmail.com |
|
|
Source of Monetary or Material Support
|
| KASTURBA MEDICAL COLLEGE, MANGALORE. |
|
|
Primary Sponsor
|
| Name |
MV SAI GOUTHAM REDDY |
| Address |
DEPARTMENT OF DVL,
KMC MANGALORE. |
| Type of Sponsor |
Other [SELF FUNDING] |
|
|
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 |
| MV SAI GOUTHAM REDDY |
KMC HOSPITAL ATTAVAR, |
KMC HOSPITAL ATTAVAR,
DEPARTMENT OF DVL,
1st FLOOR ROOM NO:10,
MANGALORE.
Dakshina Kannada
KARNATAKA |
8019922557
gouthamreddy.vr46@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ISTITUTIONAL ETHICS COMMITTEE, KASTURBA MEDICAL COLLEGE, MANGALORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L818||Other specified disorders of pigmentation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with clinical features of ADMH of either gender
2. Patients who are willing to give informed written consent for enrollment into the study. |
|
| ExclusionCriteria |
| Details |
1. Patients who are not willing to give consent
2. Patients who had exposure to drugs known to induce hyperpigmentation
3. Other causes of acquired hyperpigmentation, having a preceding inflammatory phase, e.g., fixed drug eruption, prurigo pigmentosa, post-inflammatory hyperpigmentation.
4. Other causes of acquired hyperpigmentation, without interface changes like melasma, amyloidosis and nevoid hypermelanosis
|
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Data from dermoscopic findings of this study will help in diagnosis of acquired pigmentary disorders without invasive procedures like biopsy |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study helps to diagnose acquired dermal macular hyperpigmentation through dermoscope |
Baseline |
|
|
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)
|
15/09/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/09/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response (Others) - PATIENTS DERMOSCOPY PICTURES, HISTOPATHOLOGICAL PICTURES AND DATA FROM PREDESIGNED PROFORMA.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response (Others) -
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - THROUGH PUBLIATION
- For how long will this data be available start date provided 07-01-2025 and end date provided 07-01-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
· Dermoscopy is a non-invasive OPD procedure. Histopathological findings will help to diagnose accurately. If we correlate the dermoscopic findings with histopathological findings of suspected patients with clinical features of ADMH we can reduce the invasive procedures in near future. · This study will help in assessing the correlation between clinical, dermoscopic and histopathological findings in ADMH. · Dermoscopy can minimise the need to do biopsy for diagnosis in suspected ADMH patients |