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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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