Treatment of Skin Severity in Ichthyosis with Hyperbaric Oxygen Therapy

Phase 2

Completed

• Conditions: common ichtyosis; Ichtyosis vulgaris; 10040789; 10004018; 10011063

• Registration Number: NL-OMON55363
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Trial ended prematurely

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-05-19
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1

Inclusion Criteria

- Confirmed diagnosis ichthyosis
- > 18 years

Exclusion Criteria

- Unfit for hyperbaric oxygen therapy as assessed by the hyperbaric physician
- Language barrier or unable to give informed consent
- Smoking or quit smoking < 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Assessing the safety and feasibility of HBO in patients with ichthyosis.<br /><br>- Changes in histologic findings in skin biopsies<br /><br>- Changes in laboratory findings (general lab and infection parameters)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Changes in PROMs (Patients Global Assessment, pain, desquamation, sleep and<br /><br>pruritus scores, medication usage and Quality of life using skindex-29) before,<br /><br>directly after, two months after, six months after and twelve months after HBO.<br /><br>- Changes in doctors reported outcomes (objective skin scoring with IGA-NS,<br /><br>TLSS NS and BSA)<br /><br>before, directly after, two months after, six months after and twelve months<br /><br>after HBO.<br /><br>- Side effects of HBOT<br /><br>- Regret analysis</p><br>