Treatment of Ichthyosis with Hyperbaric Oxygen Therapy
Phase 1
- Conditions
- ichthyosisTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]MedDRA version: 20.0Level: PTClassification code 10021198Term: IchthyosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
- Registration Number
- EUCTR2019-003601-10-NL
- Lead Sponsor
- Amsterdam University Medical Centers
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 6
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
- 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - Assessing the safety and feasibility of HBO in patients with ichthyosis. <br>- Improvement in physiological findings (lab work, skin biopsy)<br>;Secondary Objective: - Quality of life (patient and doctor reported)<br>- Use of concomitant medication <br>- Complications of HBOT<br> <br>;Primary end point(s): -Feasability of treatment in patient population (adherence to therapy, regret analysis)<br>-Laboratory findings (leukocyte count, leukocyte differentiation, CRP, sedimentation and cytokine panel including IL1, IL2, IL6, IL10, TNF-a and IFN-?) <br>-Histologic changers in skin biopsy<br>;Timepoint(s) of evaluation of this end point: 0, 4, 8, 20 and 44 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -Patient-reported outcome (POEM, pain, desquamation, sleep and pruritus scores, medication usage and skindex-29) <br>-Doctor-reported outcome measures (objective skin scoring with IGA-NS, TLSS NS and BSA)<br><br>;Timepoint(s) of evaluation of this end point: 0, 4, 8, 20 and 44 weeks