We are pleased to share that we have now received the results from the Pharmaxis Solaria Scar Cream Trial led by Professor Fiona Wood, Senior Research Lead Mark Fear, and Trial Clinical Manager Dr Natalie Morellini have been released.
The primary objective of the phase 1 trial was to investigate the safety and tolerability of the novel topical drug treatment Solaria. The trial recruited 42 people with a scar that was at least one year old (any type) to participate in the double-blind study over a three-month period and either applied a placebo or cream three times per week. Pharmaxis has officially announced that the trial has met its primary safety objective and two secondary biomarker endpoints in patients with established scars.
Trial key results:
- Well tolerated with a good safety profile
- Marked change in scar composition with 30% reduction in collagen content
- First-ever proof that LOX inhibition reduces skin collagen underpins the expansion of Pharmaxis and Professor Fiona Wood collaboration into new skin fibrosis indications
- No overall improvements in scar appearance seen at 3 months points to need for longer study in established scars
Fiona shared the following comments about the trial with Pharmaxis:
“This exploratory clinical study has significantly enhanced our understanding of the role of LOX enzymes in scarring and the scar process itself. PXS-6302 safely inhibits these key enzymes to a significant degree and leads directly to an unprecedented change to the scar composition that we have not seen with any other form of treatment. We estimate that up to 50% of the excess collagen in these patients’ scars has been removed and while the length of this Phase 1c safety study was not sufficient to change the appearance of an established scar the remodelling process will be ongoing and I’m confident we would see an improvement in scar appearance and physical characteristics if we observed them for longer.
“The collected data also bodes well for studying the effect of LOX inhibition on the prevention of scars after surgery and in younger scars where the remodelling process is more aggressive and probably more sensitive to intervention with a LOX inhibitor. This work is a particular passion of mine and I am looking forward to extending our collaboration with Pharmaxis for future studies.”
The Foundation is thrilled that phase 1 of the trial has confirmed that the Solaria cream is considered safe and met its first milestone of the research process. We would like to acknowledge Trial Clinical Manager Dr Natalie Morellini for her role in the smooth execution and supervision of the trial. Additionally, we want to thank all the participants for their time and commitment to helping generate new knowledge that supports our research efforts.
We remain passionate about reaching our vision of scarless healing in mind and body. Trials such are this are a vital part of the research process. From here, our researchers will continue to analyse the results of phase one and look to continue to the next clinical trial phase.
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