| CTRI Number |
CTRI/2025/07/091608 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study on people with thickened, darkened skin over neck and underarms |
|
Scientific Title of Study
|
A Cross-Sectional Study on Acanthosis Nigricans: Clinical, Dermoscopic and Artificial Intelligence-Assisted Assessment in a Tertiary Care Hospital in South India |
| 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 Rudrani Mukherjee |
| Designation |
Junior Resident, MD Dermatology |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Room number 21, OPD Block
Department of Dermatology
Kasturba Medical College
Madhav nagar
Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9836863999 |
| Fax |
|
| Email |
rudranimukherjee1@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Smitha Prabhu S |
| Designation |
Guide - /Professor and Head of Department |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Room number 21, OPD Block
Department of Dermatology
Kasturba Medical College
Madhav nagar
Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9448910972 |
| Fax |
|
| Email |
smitha.prabhu@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Smitha Prabhu S |
| Designation |
Guide - /Professor and Head of Department |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Room number 21, OPD Block
Department of Dermatology
Kasturba Medical College
Madhav nagar
Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9448910972 |
| Fax |
|
| Email |
smitha.prabhu@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Madhavnagar,
Manipal – 576104
Udupi District, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Rudrani Mukherjee |
| Address |
Department of Dermatology, Kasturba Medical College Madhavnagar, Manipal - 576104 |
| 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 Rudrani Mukherjee |
Kasturba Hospital |
Department of Dermatology, Room no. 21, OPD Block,
Kasturba Medical College,
Manipal - 576104 Udupi KARNATAKA |
9836863999
rudranimukherjee1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L83||Acanthosis nigricans, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. All children (aged 7 years and above) and adults (aged 18 years and above) with the clinical diagnosis of acanthosis nigricans (AN) who visit the Dermatology outpatient department of Kasturba Hospital, Manipal |
|
| ExclusionCriteria |
| Details |
1. Patients with dermatological conditions in flexures which mimic acanthosis nigricans like Acquired Dermal Macular Hyperpigmentation (ADMH), Confluent and reticulated papillomatosis (CRP)
2. Patients with dermatological conditions in flexures which can mask acanthosis nigricans like dermatophytosis, flexural psoriasis, erythrasma
3. Patients who have received topical treatments for AN within the past 1 month
4. Patients who do not consent to the study (for patients of 7-18 years, patient’s assent and parent/ guardian’s consent needed)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of Different Types of Acanthosis Nigricans (AN) in the Population |
24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Dermoscopic Grading Criteria for Acanthosis Nigricans
|
24 months |
Association of Acanthosis Nigricans with Visceral Adiposity Index (VAI)
|
24 months |
| Efficiency of AI Grading compared to Clinical Grading (Burke’s Scale) |
24 months |
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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)
|
01/08/2025 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This prospective cross-sectional study, titled “A Cross-Sectional Study on Acanthosis Nigricans: Clinical, Dermoscopic, and Artificial Intelligence-Assisted Assessment,” aims to evaluate 150 patients with clinically diagnosed Acanthosis Nigricans (AN) over a two-year period (July 2025 to June 2027) at a tertiary care hospital in South India. The study will classify the types of AN, clinically grade AN using Burke’s grading scale, assess the correlation of AN with metabolic indicators such as the Visceral Adiposity Index (VAI) and identify specific features of AN on dermoscopy. An innovation in the study is the use of artificial intelligence (AI) to assist in grading AN from standardized clinical images, comparing its accuracy and reliability with traditional clinical assessment. The inclusion criteria involve adults and children (aged 7 and above) with clinically evident AN, while patients with mimicking conditions, recent treatments, or unwillingness to consent are excluded. Each participant will undergo a detailed clinical evaluation, dermoscopic imaging and AI-assisted image analysis. The study will develop a dermoscopic grading system to complement clinical evaluation. Statistical analysis will be performed using SPSS, applying correlation tests, chi-square, t-tests, and Cohen’s Kappa for inter-rater reliability. The primary outcomes include identifying clinical and dermoscopic patterns of AN, exploring the correlation with metabolic parameters, and evaluating AI performance in grading AN. The project is self-funded, with budget of Rs 2,000 allocated for printing study materials. |