Outcome measure
Hyperhidrosis Disease Severity Measure — Axillary, 7-day recall (HDSM-Ax-7)
The Hyperhidrosis Disease Severity Measure - Axillary, 7-day recall (HDSM-Ax-7) is a patient-reported instrument scored 0–10 and used as the primary endpoint in the CARDIGAN-1 and CARDIGAN-2 Phase 3 trials supporting Sofdra (sofpironium).
- Type
- patient reported
- Scale
- 0 – 10
- Consumer-facing?
- No
- Primary use
- Sofdra (CARDIGAN-1, CARDIGAN-2) primary endpoint
Why a 7-day recall?
Daily diaries (like the ASDD used in Qbrexza trials) generate a continuous data stream but require daily patient adherence. A 7-day-recall instrument reduces patient burden while still capturing a defined window of experience. The CARDIGAN program adopted HDSM-Ax-7 for its primary axillary measure of patient-reported severity.
How to interpret HDSM-Ax-7 changes
Primary endpoint definitions typically involve a ≥2-point improvement from baseline at the trial timepoint. Trial summaries and the Sofdra label report response rates at day 43; specific values render through governed claim packets as they resolve.
Reading paths
·Related references
Read related evidence.
Treatments scored with this measure