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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05211830 on ClinicalTrials.gov