Follow-up treatment with Gladskin in patients with Netherton syndrome (NS)

Follow-up treatment with Gladskin in patients with Netherton syndrome (NS) - Follow-up treatment with Gladskin in patients with Netherton syndrome

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48716

Enrollment

Registered

2018-12-03

Start date

2019-02-06

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

ichtyosis Netherton syndrome

Interventions

- Run in phase to monitor current treatment using medication diary (week 0-2) - Apply Gladskin on the skin twice daily (intervention phase: week 3-10) - Follow up phase to monitor treatment and severi

Eligibility

Age

18 Years to 99 Years

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

Measure	Time frame
1. Patient reported disease severity score using the Patient Global Assessment (PGA)	—

Secondary

Measure	Time frame
1. Patient reported disease severity scores - Pruritus Numerical Rating Scale (Pruritus NRS) - Pain Numerical Rating Scale (Pain NRS) - Desquamation Numerical Rating Scale (Desquamation NRS) - Erythema Numerical Rating Scale (Erythema NRS) - Sleep Numerical Rating Scale (Sleep NRS) 2. Doctor reported disease severity scores: - Skin infection defined by the use of topical *or systemic antibiotics - Visual index for Ichthyosis severity (VIIS) 4. S. aureus load and other microorganisms on skin and nose mucosa measured by DNA based methods and culture. 5. Quality of life using Skindex-29 questionnaires 6. Safety and tolerability of Gladskin: - Adverse device effect, therapy cessation for adverse device effects - Serious Adverse Device Effect (SADE) - Blood tests including infection parameters (leukocytes, total and differentiation), renal function (creatinine, eGFR), liver function tests (ASAT, ALAT, bilirubin).	—

Measure

Time frame

1. Patient reported disease severity scores - Pruritus Numerical Rating Scale (Pruritus NRS) - Pain Numerical Rating Scale (Pain NRS) - Desquamation Numerical Rating Scale (Desquamation NRS) - Erythema Numerical Rating Scale (Erythema NRS) - Sleep Numerical Rating Scale (Sleep NRS) 2. Doctor reported disease severity scores: - Skin infection defined by the use of topical *or systemic antibiotics - Visual index for Ichthyosis severity (VIIS) 4. S. aureus load and other microorganisms on skin and nose mucosa measured by DNA based methods and culture. 5. Quality of life using Skindex-29 questionnaires 6. Safety and tolerability of Gladskin: - Adverse device effect, therapy cessation for adverse device effects - Serious Adverse Device Effect (SADE) - Blood tests including infection parameters (leukocytes, total and differentiation), renal function (creatinine, eGFR), liver function tests (ASAT, ALAT, bilirubin).

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)