Faculty of Medicine Cairo University
Cairo, Cairo Governorate, 11553, Egypt
NCT Number: NCT07294313
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).
Trial opening soon.
Get Notified12 year–50 year
All sexes
Observational
Cairo, Cairo Governorate, 11553, Egypt
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
for the patient group:
Inclusion criteria
Exclusion criteria
by clinical and trichoscopic examination:
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).
Time frame: 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.
Time frame: 1 year
Assess accuracy, sensitivity, specificity and positive predictive value of the trained AI models in assessment of severity of androgenetic alopecia as regards:
Time frame: 1 year
To compare the model's diagnostic accuracy using the macroscopic versus trichoscopic images alone
Contact information is provided by the study sponsor or research team.
Ahmed Mourad, MD
CONTACT
Noura Nour, MSc, MBBCh
CONTACT
Cairo University
Other
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