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Standardization of Lesion Classification and Assessment by Investigators in Clinical Trials for Hidradenitis
Amit Garg1, Andrew Strunk1, Bria Midgette1
1Northwell, New Hyde Park, New York.
JAMA Dermatology
|November 26, 2025
Summary
Standardized definitions for hidradenitis suppurativa (HS) lesions improve clinical trial data. Consensus was reached on HS lesion morphology and assessment guidance, enhancing investigator reliability in trials.
Area of Science:
- Dermatology
- Clinical Trials
- Medical Imaging
Background:
- Accurate assessment of hidradenitis suppurativa (HS) lesions is crucial for clinical trial outcomes.
- Investigator reliability in HS lesion classification impacts data quality and responder status determination.
Purpose of the Study:
- To establish consensus-based morphological definitions for HS lesions.
- To develop standardized guidance statements for investigator lesion assessments in clinical trials.
Main Methods:
- Expert health professionals and novice raters assessed HS lesion images.
- Morphological definitions and guidance statements were formulated based on feedback.
- Two rounds of electronic Delphi surveys with virtual discussion facilitated consensus voting.
Main Results:
- Consensus was achieved for 9 out of 11 morphological definitions (≥90% agreement).
- 16 of 18 guidance statements reached consensus (13 endorsed by >80%).
- Two guidance statements regarding tunneled plaques and scalp lesions did not reach consensus.
Conclusions:
- Standardized morphologic definitions and assessment guidance for HS lesions can improve accuracy and reliability.
- Implementation in clinical trial protocols and investigator training is recommended.
- These standards aim to enhance overall data quality in HS clinical research.
