A world-first human trial found that a new topical wound healing cream is safe and well tolerated in healthy participants.
New results from a Phase 1 clinical trial show that a topical wound healing cream, developed by researchers from the University of Western Australia and industry partner Pharmaxis, is safe and well tolerated.
The world-first human trial was led by Prof Fiona Wood AM from UWA’s Medical School, who said the drug was not only safe, but also effective at inhibiting enzymes involved in scarring.
“Scars are a constant reminder of trauma with both physical and psychological impact. Our aim is to reduce the scar and reduce the impact,” Prof Wood said.
The study involved a group of healthy volunteers, who tested four different strengths of this cream, formulated as an easy-to-apply single dose cream.
According to principal investigator Dr Kylie Sandy-Hodgetts, from UWA’s School of Biomedical Sciences, now that their new drug was deemed safe, the next step was to move forward to the next phase.
“Based on the encouraging results from the phase 1 study in healthy volunteers, we are now preparing for a study in patients with established scars,” Dr Sandy-Hodgetts said.
“We will be investigating the safety of three months’ treatment with the drug, and exploring if three months’ treatment, at a dose that we now know will significantly inhibit an enzyme implicated in scar formation, can make a difference to both the appearance and structure of their scars.”
The new healing cream even has potential to help treat old scars. According to Dr Mark Fear, Senior Research Fellow at the Stan Perron Centre for Excellence in Childhood Burns, the new healing cream had shown promising results in pre-clinical models of scar tissue development.
“We now understand from our research that even scars which are stable and many years old are in fact replenishing a significant proportion of mature, stiff collagen in a matter of a few months. This presents an opportunity for a drug like PXS-6302 to potentially improve even established scars,” Dr Fear said.