Treatment of Ichthyosis with Hyperbaric Oxygen Therapy

Treatment of Skin Severity in Ichthyosis with Hyperbaric Oxygen Therapy - HOT-TreSSI

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003601-10-NL

Enrollment

Registered

2020-06-23

Start date

2020-09-18

Completion date

Unknown

Last updated

2020-11-23

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

Conditions

ichthyosis MedDRA version: 20.0 Level: PT Classification code 10021198 Term: Ichthyosis System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Trade Name: Zuurstof medicinaal gasvormig SOL, 100% v/v medicinaal gas, samengeperst Pharmaceutical Form: Inhalation vapour

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Confirmed diagnosis ichthyosis - > 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: - Assessing the safety and feasibility of HBO in patients with ichthyosis. - Improvement in physiological findings (lab work, skin biopsy) ;Secondary Objective: - Quality of life (patient and doctor reported) - Use of concomitant medication - Complications of HBOT ;Primary end point(s): - Feasability of treatment in patient population (adherence to therapy, regret analysis) - Laboratory findings (leukocyte count, leukocyte differentiation, CRP, sedimentation and cytokine panel including IL1, IL2, IL6, IL10, TNF-a and IFN-?) - Histologic changers in skin biopsy ;Timepoint(s) of evaluation of this end point: 0, 4, 8, 20 and 44 weeks	—

Measure

Time frame

Main Objective: - Assessing the safety and feasibility of HBO in patients with ichthyosis. - Improvement in physiological findings (lab work, skin biopsy) ;Secondary Objective: - Quality of life (patient and doctor reported) - Use of concomitant medication - Complications of HBOT ;Primary end point(s): - Feasability of treatment in patient population (adherence to therapy, regret analysis) - Laboratory findings (leukocyte count, leukocyte differentiation, CRP, sedimentation and cytokine panel including IL1, IL2, IL6, IL10, TNF-a and IFN-?) - Histologic changers in skin biopsy ;Timepoint(s) of evaluation of this end point: 0, 4, 8, 20 and 44 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): - Patient-reported outcome (POEM, pain, desquamation, sleep and pruritus scores, medication usage and skindex-29) - Doctor-reported outcome measures (objective skin scoring with IGA-NS, TLSS NS and BSA) ;Timepoint(s) of evaluation of this end point: 0, 4, 8, 20 and 44 weeks	—

Countries

Netherlands

Contacts

Public ContactAMC

Amsterdam University Medical Centers

31205665740

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026