Clinical Trial of Treatment to Prevent Scars

UWA and Fiona Stanley Hospital researchers are conducting a world-first clinical trial that could make scars a thing of the past.


A new drug, called PXS‐6302, is currently being tested in a world-first clinical trial co-led by Professor Fiona Wood AM, and Dr Kylie Sandy-Hodgetts, bringing together researchers from the University of Western Australia (UWA) and Fiona Stanley Hospital. The new drug aims to prevent scars from forming after a traumatic event, surgery, and particularly after serious burns.

Among scar-causing injuries, burns are among the most common. In Australia, more than 50,000 burns related hospital admissions occur every year, according to the Australian and New Zealand Burn Association

“It’s exciting for the research team to explore a novel path to reduce scarring and to be moving closer to that goal. Scar‐less healing is the vision that has motivated our work over many decades,” Prof Fiona Wood said in a press release.

About this drug
Our skin is the largest organ in our body, and has important functions such as protecting us from microbes and environmental elements, like water; it helps regulate body temperature, and allows for the sensation of touch, cold and heat. An important property of our skin is its flexibility, a property largely possible due to the presence of a protein called collagen. In normal, un-injured skin, there is a layer of collagen with a “basket-weaved”-like structure, which grants skin its structural properties. However, in injured skin the scar tissue that forms is completely different.

“In scar tissue the collagen (predominantly Collagen I) is more densely packed and closely aligned in parallel bundles,” Dr Kylie Sandy-Hodgetts, Senior Research Fellow at the University of Western Australia, Director of the Skin Integrity Research Institute and co-lead researcher in this new clinical trial told Medical Forum.

“These changes both in structure and quantity of collagen largely underlie the poor appearance of scars and lead to loss of pliability, discomfort and functional problems,” she added.

The new drug targets a key enzyme involved in the development of scar tissue and has, so far, shown promising pre-clinical results in animal models.

“…PXS-6302, a discovery drug by industry partner Pharmaxis Ltd, is effective in the inhibition of enzymatic activity of the enzyme lysyl oxidase (LOX), which will impede collagen cross-linking, attenuating levels of insoluble collagen and leading to amelioration of the scar and/or skin fibrosis. As such, PXS-6302 provides a promising novel therapeutic approach for the treatment of skin fibrosis and scarring,” Dr Sandy-Hodgetts said.

If these results translate to humans too, using PXS‐6302 could potentially avoid the need of invasive procedures, like surgery or laser treatment.

About this trial
The new clinical trial is testing the safety and tolerability of PXS‐6302 in healthy volunteers and will also inform researchers about the correct dosing and application regimen for further studies. This is the first step needed before the drug can reach patients with acute and chronic scarring. “Pre-clinical studies are promising, however human trials are required to determine the therapeutic benefit of this particular compound. We anticipate the Phase I component will be completed by mid-2021 and commencement of Phase II studies will commence shortly thereafter,” Dr Sandy-Hodgetts told Medical Forum.

“Plans for the future include further research into novel ways of prevention, treatment and clinical management of wounds such as scarring, burns and surgical wound complications.  The translation of research findings into clinical practice is the ultimate goal in order to improve the lives of patients with wounds,” Dr Sandy-Hodgetts added.