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Mount Sinai Dermatology

SITE-DERM-003-002

ActiveHealthy · 10

Enrolled

22

Screen fail %

21.1%

Open queries

1

Risk score

11

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. Ethan Park
Site coordinator
New Site Coordinator
Monitor (CRA)
CRA — USA region

Recent activity

DateKindSummaryActor
2026-09-10EnrollmentNew subject enrolled (Subject 0042)Dr. Ethan Park
2026-09-07Monitoring visitCRA monitoring visit completed; 12 SDV checks closedCRA team
2026-09-03Query resolvedTwo open queries resolved by site coordinatorSite coordinator
2026-08-29SignatureProtocol amendment v3 signed by PIDr. Ethan Park
2026-08-22Query openedData management opened query on AE form (Subject 0031)Data management

Deviation history

DateSeverityTitleCAPAStatus
2026-08-13minorInformed consent re-consent window exceededSite retrained on v3 protocol; tracker added.open