跳至主要内容
临床试验/CTRI/2025/07/091608
CTRI/2025/07/091608招募中不适用

A Cross-Sectional Study on Acanthosis Nigricans: Clinical, Dermoscopic and Artificial Intelligence-Assisted Assessment in a Tertiary Care Hospital in South India

Dr Rudrani Mukherjee1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
Prevalence of Different Types of Acanthosis Nigricans (AN) in the Population

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
7.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • Patients with dermatological conditions in flexures which mimic acanthosis nigricans like Acquired Dermal Macular Hyperpigmentation (ADMH), Confluent and reticulated papillomatosis (CRP)
  • Patients with dermatological conditions in flexures which can mask acanthosis nigricans like dermatophytosis, flexural psoriasis, erythrasma
  • Patients who have received topical treatments for AN within the past 1 month
  • Patients who do not consent to the study (for patients of 7-18 years, patient’s assent and parent/ guardian’s consent needed).

结局指标

主要结局

Prevalence of Different Types of Acanthosis Nigricans (AN) in the Population

时间窗: 24 months

次要结局

  • Dermoscopic Grading Criteria for Acanthosis Nigricans
  • Association of Acanthosis Nigricans with Visceral Adiposity Index (VAI)
  • Efficiency of AI Grading compared to Clinical Grading (Burke’s Scale)(24 months)

研究者

发起方
Dr Rudrani Mukherjee
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Rudrani Mukherjee

Kasturba Medical College Manipal

研究点 (1)

Loading locations...

相似试验