None listed
Conditions
Brief summary
The result of injury in humans is scar formation. In the case of burn injuries, particularly larger surface area and deeper burn injuries, extensive scar formation has a significant physical and psychosocial impact on patients after recovery. Scar formation after injury is driven initially by the inflammatory response but subsequently by matrix producing cells (fibroblasts) that generate excess collagen. This collagen is organized in parallel bundles and the excess collagen as well as organization of collagen underpins the poor appearance and physical properties of scar. A family of 5 lysyl oxidase (LOX, LOXL1-4) enzymes are involved in a process of cross-linking collagen. This cross-linking is increased in scars. This study will test an inhibitor of these enzymes, PXS 5505, in burn patients with moderate burn injuries and that require surgery. The study will test the safety of PXS-5505 when given to burn patients after their surgery and also measure the scarring after their recovery. The study will be a double-blind and randomised controlled trial with 60 patients randomised 2:1 to PXS-5505 or placebo.
Interventions
Participants will receive PXS-5505 at a dose of 200mg twice daily in oral capsules for 26 weeks. PXS-5505 will be dispensed at baseline (start of treatment), and at 4, and 12 week visits after the start of treatment. Unused capsules will be returned at 4, 12 and 26 week visits in order to assess compliance. Each time treatment is dispensed, subjects will be provided with a diary containing dosing instructions where they can log each dose taken and any issues.
Sponsors
university of western australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
21 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Aged between 21 and 60 years (inclusive). 2. Acute burn injury of >=5% and <=15% total body surface area (TBSA) requiring treatment with a split-thickness skin graft 3. Agree to use of adequate contraception if participant/partner of childbearing age. 4. Have given written informed consent to participate in this study in accordance with local regulations. 5. Able to understand, give consent, and comply with all scheduled study visits, procedures and restrictions.
Exclusion criteria
1. Clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, skin, or cardiovascular disease or any other condition, that, in the opinion of the Principal Investigator, would jeopardize the safety of the subject or impact the validity of the study results. 2. History of immediate hypersensitivity to any medication or currently suffers from clinically significant systemic allergic disease. 3. Alanine aminotransferase (ALT) and/or), aspartate aminotransferase (AST) >3.0 x), or bilirubin>2.5 × upper limit of normal (ULN) or direct bilirubin >1.5 ULN.). 4. Evidence of significant renal insufficiency, as indicated by an estimated creatinine clearance using the Cockcroft-Gault formula of less than 50 mL/min at Screening. 5. Have participated in a clinical trial or have received an experimental therapy within 30 days or 5 half-lives of the drug, whichever is longer, prior to dosing. 6. Active systemic infection 7. History of aneurysm
Outcome results
None listed