A Study to Evaluate Topically Applied SXR1096 Cream in Patients With Netherton Syndrome
NCT05211830 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2025-12-16
Summary
In this phase I/II trial a topical skin cream with the active substance SXR1096 will be tested in patients with Netherton syndroms, a rare inflammatory skin disease. SXR1096 is a specific and potent protease inhibitor that can inhibit the proteases kallikrein 5, 7 and 14 - all recognised as up-regulated and causing the disease state in Netherton syndrome patients. Patients will be treated for one month with active cream and placebo cream at different areas of the skin.
Conditions
Interventions
- DRUG
-
SXR1096 cream
Skin cream to be applied twice a day to a predefined area of the skin
- DRUG
-
Placebo cream
Skin cream to be applied twice a day to a predefined area of the skin
Sponsors & Collaborators
-
Sixera Pharma
lead INDUSTRY
Principal Investigators
-
Maarten de Chateau, MD PhD · Sixera Pharma
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-07
- Primary Completion
- 2025-06-10
- Completion
- 2025-08-20
Countries
- Austria
- France
- Germany
- Sweden
Study Locations
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