Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000269437
Ethics application status
Approved
Date submitted
27/03/2025
Date registered
10/04/2025
Date last updated
10/04/2025
Date data sharing statement initially provided
10/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1c Study Investigating the SAfety and TolErability of a LysyL Oxidase InhibiTor (PXS-6302) in the amElioration of Keloids
Scientific title
A Phase 1c Study Investigating the SAfety and TolErability of a LysyL Oxidase InhibiTor (PXS-6302) in the amElioration of Keloids
Secondary ID [1] 313356 0
none
Universal Trial Number (UTN)
Trial acronym
The SATELLITE study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
keloid 335713 0
Condition category
Condition code
Skin 332279 332279 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 329942 0
Treatment: Drugs
Comparator / control treatment
Placebo - paraffin/petroleum jelly based cream. This is provided to participants with >1 keloid but not to those participants with only 1 keloid.
Control group
Placebo

Outcomes
Primary outcome [1] 340868 0
Incidence and severity of adverse events (AE)
Timepoint [1] 340868 0
Day 1, 4 weeks, 8 weeks, 13 weeks (3months) after commencing treatment phase of study (after 4 week placebo run-in period is completed). Primary timepoint is 3 months after commencing treatment
Primary outcome [2] 340869 0
Change in keloid volume from baseline
Timepoint [2] 340869 0
3 months after commencement of treatment phase
Secondary outcome [1] 445301 0
Change in patient/observer reported measures
Timepoint [1] 445301 0
Day 1 (Baseline), 4 weeks, 8 weeks, 3 months after commencement of treatment phase
Secondary outcome [2] 445302 0
change in observer assessment of scar
Timepoint [2] 445302 0
Day 1 (baseline), 4 weeks, 8 weeks, 3 months after commencement of treatment phase
Secondary outcome [3] 445303 0
Observer scar assessment
Timepoint [3] 445303 0
Day 1 (baseline), 4 weeks, 8 weeks, 3 months after commencement of treatment phase
Secondary outcome [4] 445304 0
Keloid thickness
Timepoint [4] 445304 0
Day 1 (baseline), 4 weeks, 8 weeks, 3 months after commencement of treatment phase
Secondary outcome [5] 445649 0
Tissue Stiffness/Elasticity
Timepoint [5] 445649 0
Day 1(baseline), 4 weeks, 8 weeks and 13 weeks (3 months) after commencement of treatment phase

Eligibility
Key inclusion criteria
1. Male or female and aged over 18 years at the screening visit;
2. Active keloid greater than or equal to 5cm2 and less than or equal to 25cm2 in area that has persisted for a minimum of 4 weeks;
3. A male subject is eligible to participate if he agrees to using one medically approved (i.e., mechanical or pharmacological) contraceptive measure and have their partners agree to an additional barrier method of contraception for the duration of the study and for 90 days after the last administration of study drug; Women of childbearing potential must use effective contraception. Adequate methods of contraception include use of oral contraceptives or Depo-Provera, with an additional barrier method (diaphragm with spermicidal gel or condoms with spermicide), double-barrier methods (diaphragm with spermicidal gel and condoms with spermicide), partner vasectomy, and total abstinence;
4. Able to understand, give consent, and comply with all scheduled study visits, procedures and restrictions. If required, an interpreter will be made available.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Auricular keloids;
2. Clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, skin, or cardiovascular disease or any other condition, that, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results;
3. Current acute skin condition (e.g.: eczema, psoriasis, broken skin, wounds etc.);
4. Pregnant or breastfeeding women;
5. Received treatment of keloid in the last 3 months;
6. History of immediate hypersensitivity to any medication or currently suffers from clinically significant systemic allergic disease;
7. Are using or planning to use medications that will be applied to the area being treated in this study. There is no exclusion for other medications.
8. At Investigator discretion if systolic blood pressure 140 mmHg, diastolic blood pressure 95 mmHg, and heart rate 100 bpm;
9. At investigator’s discretion if Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or bilirubin >1.5 × upper limit of normal. Test may be repeated once at the discretion of the Investigator;
10. At investigator discretion if haemoglobin, white blood cell (WBC), neutrophils, platelets < 1.5x lower limit of normal. Test may be repeated once at the discretion of the Investigator;
11. Evidence of significant renal insufficiency, as indicated by an estimated creatinine clearance using the Cockcroft-Gault formula < 60 mL/min at Screening;
12. Receipt of blood, or loss or donation of 450 mL or more of blood within 90 days or plasma donation within 14 days before the first dose administration;
13. Have received an experimental therapy within 30 days or 5 half-lives of the study drug, whichever is longer, prior to dosing.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A as all participants eligible for randomisation will receive both treatment and placebo
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Open-label if person has a single keloid for treatment. All participants with one keloid only will receive PXS-6302 treatment.
If person has >1 keloid then allocation of one keloid to placebo and one to IP will be by a coin-toss and both participant and researcher will be blinded (double-blind)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/05/2025
Actual
Date of last participant enrolment
Anticipated
2/03/2026
Actual
Date of last data collection
Anticipated
3/08/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 27667 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 43842 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 317801 0
Commercial sector/Industry
Name [1] 317801 0
Syntara
Country [1] 317801 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
Country
Australia
Secondary sponsor category [1] 320959 0
None
Name [1] 320959 0
Address [1] 320959 0
Country [1] 320959 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316484 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 316484 0
Ethics committee country [1] 316484 0
Australia
Date submitted for ethics approval [1] 316484 0
25/10/2024
Approval date [1] 316484 0
15/01/2025
Ethics approval number [1] 316484 0
RGS0000007294

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138042 0
Prof Fiona Wood
Address 138042 0
Burns Service WA, 11 Robin Warren Drive, Murdoch, WA 6150
Country 138042 0
Australia
Phone 138042 0
+61 8 6152 2222
Fax 138042 0
Email 138042 0
[email protected]
Contact person for public queries
Name 138043 0
Mark Fear
Address 138043 0
Burn research unit, 6 verdun street, Nedlands, WA 6009
Country 138043 0
Australia
Phone 138043 0
+61 411355944
Fax 138043 0
Email 138043 0
[email protected]
Contact person for scientific queries
Name 138044 0
Mark Fear
Address 138044 0
Burn research unit, 6 verdun street, Nedlands, WA 6009
Country 138044 0
Australia
Phone 138044 0
+61 411355944
Fax 138044 0
Email 138044 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.