RecruitingPhase 1ACTRN12625000269437

A Phase 1c Study Investigating the SAfety and TolErability of a LysyL Oxidase InhibiTor (PXS-6302) in the amElioration of Keloids


Sponsor

University of Western Australia

Enrollment

20 participants

Start Date

Jun 20, 2025

Study Type

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

Keloids are raised, overgrown scars that form when the body produces too much scar tissue — often after an injury, surgery, or skin irritation. They can be itchy, painful, and distressing, and current treatments don't always work well. This Phase 1 study is testing a new topical cream called PXS-6302 to see if it is safe and whether it can reduce the size and discomfort of keloids when applied directly to the skin for three months. Up to 20 participants will take part at a single centre in Western Australia. Everyone in the study will receive the active cream on their keloid, and if they have more than one keloid, a placebo cream will be used on the others for comparison purposes. Researchers will monitor any side effects and measure changes in keloid size and symptoms over time. You may be eligible if you are aged 18 to 60 and have an active keloid that has been present for at least four weeks and measures between 5 and 25 square centimetres. You must not have keloids on your ears or have received any keloid treatment in the last three months. Pregnant or breastfeeding women, and people with significant health conditions, are not eligible.

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.

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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 PX

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)

Fiona Stanley Hospital - Murdoch

WA, Australia

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ACTRN12625000269437


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