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Outcome measure

Hyperhidrosis Disease Severity Scale (HDSS)

The Hyperhidrosis Disease Severity Scale is a validated four-point patient-reported instrument used across major hyperhidrosis trials. HDSS is the consumer-facing severity scale that maps daily-life interference to a 1–4 score and is the most useful instrument for routing patients toward appropriate care.

Type
patient reported
Scale
14
Consumer-facing?
Yes
Primary use
consumer self-assessment + clinical trial outcome

Scale points

  1. 1. My sweating is never noticeable and never interferes with my daily activities.
  2. 2. My sweating is tolerable but sometimes interferes with my daily activities.
  3. 3. My sweating is barely tolerable and frequently interferes with my daily activities.
  4. 4. My sweating is intolerable and always interferes with my daily activities.

The four answer choices

HDSS asks the patient to choose the single statement that best describes their sweating. The four canonical statements range from 'My sweating is never noticeable and never interferes with my daily activities' (score 1) to 'My sweating is intolerable and always interferes with my daily activities' (score 4). The intermediate options describe tolerable-but-sometimes-interfering (2) and barely-tolerable-frequently-interfering (3) patterns.

How it's used in trials

HDSS is a common screening criterion (e.g., requiring HDSS ≥3 for trial enrollment) and a secondary endpoint in many hyperhidrosis Phase 3 studies. The instrument's brevity and validity make it well-suited as a screening tool; for primary efficacy endpoints, longer instruments like the Axillary Sweating Daily Diary (ASDD) or HDSM-Ax-7 are more sensitive.

Validation

HDSS validity, reliability, and responsiveness were established in published validation studies. The scale tracks meaningfully with gravimetric sweat production, dermatology life-quality measures, and patient perceptions of treatment response.

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