University of Tokyo Hospital
SITE-DERM-003-004
ActiveHealthy · 11
Enrolled
20
Screen fail %
18.4%
Open queries
2
Risk score
12
Months active
22
Study assignment
- Sponsor
- Lyra Skin Sciences
- Study code
- DERM-003
- Therapeutic area
- Dermatology / Device
- Indication
- Moderate-to-severe atopic dermatitis (combination device)
Staffing
- Principal investigator
- Dr. Kenji Saito
- Site coordinator
- Tokyo Site Coordinator
- Monitor (CRA)
- CRA — Japan region
Recent activity
| Date | Kind | Summary | Actor |
|---|---|---|---|
| 2026-09-10 | Enrollment | New subject enrolled (Subject 0042) | Dr. Kenji Saito |
| 2026-09-07 | Monitoring visit | CRA monitoring visit completed; 12 SDV checks closed | CRA team |
| 2026-09-03 | Query resolved | Two open queries resolved by site coordinator | Site coordinator |
| 2026-08-29 | Signature | Protocol amendment v3 signed by PI | Dr. Kenji Saito |
| 2026-08-22 | Query opened | Data management opened query on AE form (Subject 0031) | Data management |
Deviation history
| Date | Severity | Title | CAPA | Status |
|---|---|---|---|---|
| 2026-08-13 | minor | Informed consent re-consent window exceeded | Site retrained on v3 protocol; tracker added. | open |