No registrations found.
ID
Source
Brief title
Health condition
Ichtyosis, bacterial skin infection, fungal skin infection
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasability of the intervention in this patient group; changes in PROMs (Patients Global Assessment, pain, desquamation, sleep and pruritus scores, medication usage and Quality of life using skindex-29); changes in doctors reported outcomes (objective skin scoring with IGA-NS, TLSS NS and BSA); assessing the safety and feasibility of HBO in patients with ichthyosis
Secondary outcome
Changes in laboratory findings; Changes in histologic findings in skin biopsies reviewed by a pathologist; Side effects; Regret analysis
Background summary
Ichthyosis is a group of genetically and phenotypically heterogeneous skin disorders characterized by dry, scaling skin that may be thickened or very thin and can be associated with additional cutaneous symptoms. The majority of ichthyoses are inherited. For example, Netherton syndrome (NS) is a rare autosomal recessive form of severe ichthyosis. Patients with severe ichthyoses (for example NS) suffer from chronic inflammation and skin infections because of the constant skin barrier impairment. These profound comorbidities in ichthyosis patients have a major impact on the quality of life, for which currently only symptomatic treatment is available This points out the need for alternative treatment options. Hyperbaric oxygen therapy (HBOT) has been proposed for this because of anti-inflammatory and immune-modulating effects. The therapy has been used for years in wound healing and postradiation fibrosis, and more importantly, can be applied for chronic osteomyelitis and anaerobic infections. It is generally considered safe and may help treat these frequent infections and associated symptoms. The current study is meant as pilot study to assess feasability of the treatment for this disease.
Study objective
HBOT can be used to treat the frequent superficial skin infections of patients with ichtyosis and might improve disease-associated symptoms.
Study design
0, 4, 8, 20, 44 weeks
Intervention
Hyperbaric oxygen therapy
Inclusion criteria
Confirmed diagnosis of ichtyosis, >18 years old, can understand Dutch or English language
Exclusion criteria
Unfit for hyperbaric oxygen therapy (as determined by hyperbaric physician), unable to give informed consent, language barrier, actively smoking or stopped smoking <3 months ago
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7998 |
| CCMO | NL69300.018.20 |
| OMON | NL-OMON55363 |