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The effect of Gladskin (Staphefekt) treatment on the severity of skin symptoms in patients with Netherton syndrome

Follow-up treatment with Gladskin in patients with Netherton syndrome

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26178
Enrollment
11
Registered
2018-12-12
Start date
2019-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

The intervention includes Gladskin (Staphefekt) gel application

Sponsors

Erasmus University Medical Center Rotterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - 18 years of age or above - Having a diagnosis of Netherton syndrome - Able to read patient information, fill out online questionnaires and provide informed consent

Exclusion criteria

Exclusion criteria: - Systemic antibiotics within the previous 4 weeks - Topical antibiotics within the previous 7 days - Gladskin within the previous 7 days

Design outcomes

Primary

MeasureTime frame
Patient reported disease severity score using the Patient Global Assessment (PGA)

Secondary

MeasureTime frame
- Patient reported disease severity scores (prutitis NRS, pain NRS, desquamation NRS, erythema NRS, sleep NRS) - Visual index for Ichthyosis severity (VIIS) - Staphylococcus aureus load and other microorganisms on skin and nose mucosa measured by DNA based methods and culture - Safety and tolerability of Gladskin

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)