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临床试验/NCT07294313
NCT07294313尚未招募不适用

Harnessing Artificial Intelligence for Diagnosing Androgenetic Alopecia: A Training and Validation Study

Cairo University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2026年4月25日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
400
试验地点
1
主要终点
assessment of diagnostic capability of AI in AGA

研究概览

简要总结

The aim of this study is to develop and validate deep learning models in diagnosis of male and female pattern hair loss, and assessment of its severity based on clinical and trichoscopic image by handheld dermoscopy and administrative data (age and sex).

详细描述

The investigators intend to develop and validate artificial intelligence (AI) and machine learning (ML) models in diagnosis of male and female pattern hair loss, and assessment of its severity based on clinical and trichoscopic image using widely available and accessible handheld dermoscopes.

Conventional androgenetic alopecia (AGA) diagnosis and severity assessment are tedious and time-consuming tasks that are prone to human errors. These challenges can be tackled using artificial intelligence (AI), namely leveraging applications of machine learning and artificial neural networks for enhancing the diagnostic accuracy of scalp disease classification systems via dermoscopic image analysis. Computer aided assessment of hair microphotographs was attempted for decades, yet it faced many technical hurdles before the onset of deep learning and neural networks; and currently available software generate inaccurate results compared with visual counting. More accurate methods of analysis are needed for trichoscopic imaging, utilising deep learning image recognition models trained with a large image dataset. A number of deep learning models have been developed in recent years using videodermoscopy that achieved reliable hair density, thickness and severity classification, yet remain limited by small non-inclusive training datasets, need for hair shaving and lack of detailed reporting. Moreover, to our knowledge all previous models depend on image acquisition from expensive standalone videodermoscopy devices that lack widespread availability, rather than handheld dermoscopes that are commonly available.

The study will enroll 400 participants (200 healthy controls and 200 AGA patients). Controls undergo history and trichoscopic exams to exclude hair disorders. Trichoscopic examination will be conducted using a handheld dermoscope (CuTechs DS175) with a specialized field spacer. Patients will be assessed for disease severity using gender-specific scales. Both groups will have standardized digital and trichoscopic images taken for analysis. Images will be used to manually count and classify hairs, assess follicle units, and identify dermoscopic signs. A structured database will store all data and link clinical and image data to support objective diagnosis. AI models, particularly CNNs using transfer learning, will be trained on preprocessed images for classification and severity scoring. Model performance will be evaluated using metrics like accuracy, precision, recall, F1-score, and AUC-ROC compared with metrics reported by expert trichologists to validate accuracy and reliability

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
12 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • for the patient group:
  • Inclusion criteria:
  • Patients with male or female pattern hair loss diagnosed clinically or suspected clinically and confirmed trichoscopically
  • Age of disease onset 12-50 years old
  • Both genders
  • Any grade of androgenetic alopecia
  • Any duration of androgenetic alopecia
  • Any skin type

排除标准

  • by clinical and trichoscopic examination:
  • Patients with patchy hair loss or Telogen effluvium only.
  • Patients with cicatricial alopecia or diffuse alopecia areata
  • Patients with inflammatory scalp disorders (psoriasis, seborrheic dermatitis, lichen planopilaris and frontal fibrosing alopecia in a pattern distribution)
  • Lack of patient cooperation.
  • for the control group: apparently healthy participants not suffering from the following: AGA, patchy hair loss, cicatricial alopecia, diffuse alopecia areata, inflammatory scalp disorders (psoriasis, seborrheic dermatitis, lichen planopilaris and frontal fibrosing alopecia in a pattern distribution).

结局指标

主要结局

assessment of diagnostic capability of AI in AGA

时间窗: 1 year

Assess accuracy, sensitivity, specificity and positive predictive value of the trained AI models in differentiating AGA affected from non-AGA affected subjects using their macroscopic and trichoscopic images.

次要结局

  • assessment of severity of androgenetic alopecia using AI(1 year)
  • facilitation of AI assessment using macroscopic imagies(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Noura Adel Ahmed Abdelghany Nour

Assistant Lecturer

Cairo University

研究点 (1)

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