The SATELLITE Study
Objective: To see if a topical cream can reduce Keloids
The Fiona Wood Foundation, along with the University of Western Australia and the drug development company Syntara Ltd., are testing a study drug (PXS-6302) and its ability to treat Keloids.
What is the purpose of this research?
We are unsure why Keloids form after tissue injury. However, compared to normal skin, Keloids have more collagen (the main protein that makes up the body’s connective tissues), which leads to continued growth of fibrotic scar tissue beyond the margins of the original wound. The collagen is stable and packed because it is linked together through a process called cross-linking. Lysyl Oxidase enzymes promote crosslinking of collagen. The drug, PXS-6302, acts by preventing Lysyl oxidase enzymes from working. This makes the collagen less stable and will hopefully lead to changes in the Keloid volume over time.
The purpose of this study is to test a topical cream to see if it:
- Has any side effects and if it is well tolerated when given over 3 months?
- Reduces Keloid volume or stops growth?
- Stops or reduces Keloid symptoms of pain and itch?
What does participation in this research involve?
If you have a diagnosed Keloid on the body (not ears) and are aged between 18-60 years and you are interested in participating, we will organise a screening visit. You will have a physical exam and we will take some bloods to make sure you are in good health and can be included in the study.
- Placebo pre-treatment phase- If you are eligible and you choose to take part, you will be given a tube of placebo cream, which you will be required to apply to your Keloid 4 times per week for 4 weeks.
- Treatment phase- After the first 4 weeks you will then be given the study drug to take home and apply to your Keloid 4 times per week for 13 weeks. You will be required to come back at 4 weeks, 8 weeks and at 13 weeks for scar assessments and some blood tests/physical exams to see if the cream reduces the Keloid and is safe.
Participation Information Sheet and Consent Form
For more information the full Participation Information Sheet & Consent Form is available to read through by CLICKING HERE
Additional Information and Contact
To learn more about the SATELLITE study, please contact Natalie Morellini
Email: FSH.BurnResearch@health.wa.gov.au
Phone: 0480 370 824
This study has been approved by the SMHS Human Research Ethics Committee RGS 7294