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NCT Number: NCT07294313

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

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).

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Key information

Age range

12 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

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).

Treatment and study plan

Primary outcomes

  1. assessment of diagnostic capability of AI in AGA

    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.

Secondary outcomes

  1. assessment of severity of androgenetic alopecia using AI

    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:

    • Clinical classification (Sinclair scale for female pattern baldness and the Hamilton-Norwood scale for male pattern baldness)
    • Trichoscopic parameters: mean hair thickness (in micrometer, using planimetric analysis), hair density (frequency per cm2), proportion of terminal hairs, proportion of vellus hairs, number of hairs per follicular unit, presence of brown peripilar sign, yellow dots, and scalp honeycomb pigmentation.
  2. facilitation of AI assessment using macroscopic imagies

    Time frame: 1 year

    To compare the model's diagnostic accuracy using the macroscopic versus trichoscopic images alone

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Mourad, MD

CONTACT

[email protected]

00201021534245

Noura Nour, MSc, MBBCh

CONTACT

[email protected]

00201271451744

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2025
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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