A Phase 1c Study Investigating the SAfety and TolErability of a LysyL Oxidase InhibiTor (PXS-6302) in the amElioration of Keloids
University of Western Australia
20 participants
Jun 20, 2025
Interventional
Conditions
Summary
In this study up to 20 subjects will be enrolled at a single study centre. The study will consist of a screening period, placebo run-in period, treatment period and follow-up period. Participants will all have active keloids. Participants will be provided with PXS-6302 to apply topically (and placebo if >1 keloid requires treatment) for a period of 3 months. Safety will be assessed as frequency/type of adverse events. Exploratory measures to assess changes in the keloid (size/symptoms) will also be used.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
All participants will self-administer placebo (0% PXS-6302 cream) 4 times per week for a period of 4 weeks. At the end of this 4 week period the participant will be provided either with placebo and PXS-6302 (2%) cream or with PXS-6302 (2%) cream only dependent on whether the participant has >1 or only 1 keloid. If the participant has >1 keloid, two keloids will be treated and placebo/PXS-6302 randomised to one site each. All participants with only 1 keloid will receive PXS-6302 treatment and will not be randomised. During the treatment phase PXS-6302 - an irreversible pan-lysyl oxidase inhibitor will be applied topically four times per week to the keloid as a 2% cream formulation with a volume of 100ul per 5cm2 surface area of keloid being treated for a total duration of 13 weeks (3 months) of treatment. Participants will self-administer the treatment and adherence monitored through return of applicators at each follow-up appointment.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12625000269437