Clinical Trial: Natural History of Netherton Syndrome

Study Status: NOT_YET_RECRUITING
Recruit Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL

Official Title: Non-interventional Study of Patients With Netherton Syndrome to Characterise the Natural History of Disease

Brief Summary: The goal of this non-interventional study (NIS) is to collect real-world data to describe the natural history of Netherton Syndrome (NS).

Detailed Summary:
Sponsor: Boehringer Ingelheim

Current Primary Outcome:

For patients participating in Part 2.

IASI is a composite score that evaluates severity of erythema (subscale IASI-E) and scaling (subscale IASI-S) in different body regions as a function of their respective body surface areas.
Severity of erythema and scaling is rated on a 5-point Likert scale of 0-4 in each of 4 body regions: head and neck (including scalp), arms (including palms), legs (including soles) and trunk, prorated based on body surface area in these body regions and the percentage of involvement in each of these body regions.
The total IASI score ranges between 0-48 (i.e., sum of a maximum score of 24 for erythema and maximum score of 24 for scaling).
Higher score denotes worse clinical severity.

Original Primary Outcome:

For patients participating in Part 2.

IASI is a composite score that evaluates severity of erythema (subscale IASI-E) and scaling (subscale IASI-S) in different body regions as a function of their respective body surface areas.
Severity of erythema and scaling is rated on a 5-point Likert scale of 0-4 in each of 4 body regions: head and neck (including scalp), arms (including palms), legs (including soles) and trunk, prorated based on body surface area in these body regions and the percentage of involvement in each of these body regions.
The total IASI score ranges between 0-48 (i.e., sum of a maximum score of 24 for erythema and maximum score of 24 for scaling).
Higher score denotes worse clinical severity.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Boehringer Ingelheim

Dates:
Date Received: May 24, 2023
Date Started: 2023-08-28
Date Completion: {'date': '2023-08-28', 'type': 'ESTIMATED'}
Last Updated: 2023-06-21
Last Verified: 2023-06