| CTRI Number |
CTRI/2025/09/094202 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of various Benign Skin Tumors using Dermoscopy |
|
Scientific Title of Study
|
Observation and Documentation of Dermoscopic features of Benign Skin Growths |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anurag Mittal |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Dermatology, Venereology and Leprosy, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8223060000 |
| Fax |
|
| Email |
anuragmt00@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhushan Madke |
| Designation |
HOD and Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Dermatology, Venereology and Leprosy, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442107
India |
| Phone |
7066887353 |
| Fax |
|
| Email |
drbhushan81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anurag Mittal |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Dermatology, Venereology and Leprosy, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha
MAHARASHTRA
442001
India |
| Phone |
8223060000 |
| Fax |
|
| Email |
anuragmt00@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Anurag Mittal |
| Address |
Department of Dermatology, Venereology and Leprosy, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, Maharashtra, 442107, India |
| Type of Sponsor |
Private 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 Anurag Mittal |
Jawaharlal Nehru Medical College |
Department of Dermatology, Venereology and Leprosy, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, MH 442107
Wardha
MAHARASHTRA |
8223060000
anuragmt00@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, DMIHER (DU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D239||Other benign neoplasm of skin, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All willing participants of all genders and of all age groups with a clinical suspicion of Benign Skin Growth shall be included in the study after obtaining consent. |
|
| ExclusionCriteria |
| Details |
1. Patients with clinical suspicion of malignant skin lesions.
2. Dermoscopic features s/o malignancy.
3. Use of any topical or systemic medication for 15 days prior to visit. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A well-documented dermoscopic atlas of benign skin growths can aid dermatologists in making faster, more accurate diagnoses, particularly in resource-limited settings where access to histopathology is restricted. Additionally, it can serve as a reference for training clinicians in dermoscopic interpretation, improving overall diagnostic competency. |
At the end of the study (After 2 years) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="125"
Sample Size from India="125"
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)
|
22/09/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
RESEARCH QUESTION
Does dermoscopy aid in the diagnosis of Benign Skin Growths?
AIM
To examine and document the Dermoscopic features and correlate with Clinical examination findings in Benign Skin Growths
OBJECTIVES
1. To study the clinical features of Benign Skin Growths
2. To perform the Dermoscopic assessment of Benign Skin Growths
3. To evaluate the Clinico-Dermoscopic Correlation of Benign Skin Growths
MATERIALS AND METHODOLOGY
Study Design - 2-year Observational Analytical Study
Study population - OPD patients in AVBRH with clinical features suggestive of Benign Skin Growths
Place of study - Out-patient department of Dermatology Venereology and Leprosy.
Sample size - 125
1. Selection of 125 or more patients that present to the DVL OPD with clinical features suggestive of Benign Skin Growth
2. Explanation of the process and obtaining of written informed consent for the study.
3. Collection of demographic data, detailed history taking, thorough cutaneous examination and clinical pictures of the lesions.
4. Arriving at a provisional diagnosis through Clinical examination.
5. Dermoscopic examination, collection of Dermoscopic pictures of the same lesion and arriving at a final diagnosis. (Patients with Dermoscopy suggestive of malignancy will be rejected and treated appropriately)
6. Correlate, the Clinical findings with the Dermoscopic findings and the provisional and the final diagnosis made from the two.
OUTCOME
A well-documented dermoscopic atlas of benign skin growths can aid dermatologists in making faster, more accurate diagnoses, particularly in resource-limited settings where access to histopathology is restricted. Additionally, it can serve as a reference for training clinicians in dermoscopic interpretation, improving overall diagnostic competency. |