Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000258459
Ethics application status
Approved
Date submitted
13/12/2024
Date registered
9/04/2025
Date last updated
4/06/2025
Date data sharing statement initially provided
9/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Topical Gel for Tophaceous Gout
Scientific title
Six-month, single-centre, triple-blind, cross-over, placebo-controlled clinical trial of the effect of topical MDCX101 Gel in people with tophaceous gout
Secondary ID [1] 313563 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tophaceous gout 336073 0
Condition category
Condition code
Musculoskeletal 332621 332621 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomized to either the active study gel or the placebo gel for the first three months, and then the other treatment for second three months with no washout period. Study gel will be the MDCX101 Gel (active treatment gel containing menthol, cajeput and clove oil). Participants will be instructed to apply the gel twice daily to the index tophi as well as the first metatarsophalangeal (MTP1) joints. Written instructions will also be provided. In total, a maximum of 2 cm (1g) gel will be used at each application. Each tube contains 50g of gel, so 4 tubes per participant will be provided for three months use (allowing dosing for 3 months and 10 days). The weights of the tubes will be measured at each study visit.
Intervention code [1] 330154 0
Treatment: Other
Comparator / control treatment
Placebo gel will be identical in appearance and smell (a clear gel containing menthol, cajeput and clove oil).
Control group
Placebo

Outcomes
Primary outcome [1] 340138 0
The primary aim of this trial is to evaluate the effects of MDCX101 Gel on reducing monosodium urate (MSU) crystal deposits in people with tophaceous gout.
Assessment method [1] 340138 0
Change in MSU crystal volume at index tophi and the first metatarsophalangeal joints (MTP1) on dual energy computed tomography after three months of treatment from baseline to 3 and 6 months post-commencement of intervention. This will be assessed as a composite outcome.
Timepoint [1] 340138 0
Baseline, 3 and 6 months (primary timepoint) post-commencement of intervention.
Secondary outcome [1] 442924 0
To evaluate the effects of MDCX101 Gel in people with tophaceous gout on changes in subcutaneous tophus size.
Assessment method [1] 442924 0
For each index tophus, the longest tophus diameter and its perpendicular length measured by Vernier calipers.
Timepoint [1] 442924 0
Baseline, 3 and 6 months post-commencement of intervention.
Secondary outcome [2] 442926 0
To assess participant global assessment of response to treatment.
Assessment method [2] 442926 0
Participant global assessment of response to treatment, measured using a 0-10 numerical rating scale (NRS).
Timepoint [2] 442926 0
3 and 6 months post-commencement of intervention.
Secondary outcome [3] 442927 0
To evaluate the tolerability and safety of the MDCX101 Gel.
Assessment method [3] 442927 0
Participant assessment of residue after treatment application, measured using a 0-10 numerical rating scale (NRS). Participant assessment of skin irritation after treatment application, measured using a 0 - 10 numerical rating scale (NRS).
Timepoint [3] 442927 0
Baseline, 3 and 6 months post treatment initiation.
Secondary outcome [4] 444080 0
To evaluate the effects of MDCX101 Gel in people with tophaceous gout on pain due to gout.
Assessment method [4] 444080 0
Participant questionnaire using a 1-10 numerical rating system (NRS).
Timepoint [4] 444080 0
Baseline, 3 and 6 months post treatment initiation.
Secondary outcome [5] 444081 0
To evaluate the effects of MDCX101 Gel in people with tophaceous gout on joint stiffness.
Assessment method [5] 444081 0
Participant questionnaire of joint stiffness measured using a 0-10 numerical rating scale (NRS).
Timepoint [5] 444081 0
Baseline, 3 and 6 months post commencement of intervention.
Secondary outcome [6] 444082 0
To evaluate the effects of MDCX101 Gel in people with tophaceous gout on frequency of gout flares.
Assessment method [6] 444082 0
Number of gout flares recorded in a gout flare diary. Participants will be provided with a gout flare diary which will be completed at the time of a gout flare.
Timepoint [6] 444082 0
The 0-10 numerical rating scale (NRS) will be completed every 12 hours from the time of gout flare onset until the gout flare has resolved.
Secondary outcome [7] 444084 0
To evaluate the effects of MDCX101 Gel in people with tophaceous gout on pain during a gout flare.
Assessment method [7] 444084 0
Participants will be provided with a gout flare diary which will be completed at the time of a gout flare. This will include a 0-10 numerical rating scale (NRS) for pain, which will be completed every 12 hours from the time of gout flare onset until the gout flare has resolved.
Timepoint [7] 444084 0
Diaries will be collected at 3 and 6 months.

Eligibility
Key inclusion criteria
• Age 18 years and over
• Gout according to the 2015 ACR/EULAR criteria
• Ability to provide written informed consent for participation in the clinical trial
• Willing to comply with the study protocol and attend all study visits
• At least one clinically evident subcutaneous tophus that is not discharging or within a bursa (measurable tophus)
• Serum urate greater than or equal to 0.24 mmol/L
• On stable urate-lowering therapy for at least one month with no planned changes to treatment during the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Known allergies to gel ingredients
• Eczema, dermatitis, or other active skin condition
• Use of other topical treatment for gout
• Estimated glomerular filtration rate (eGFR) <30ml/min/1.73m2
• Unstable co-morbid health conditions (e.g. NYHA stage 4 heart failure, recent (within 6 months) myocardial infarction, advanced cancer, dementia; poorly controlled diabetes)
• Females of child-bearing age not on contraception
• Pregnant or breastfeeding

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)
Treatment packs will be labelled by study number according to the randomisation schedule with the four tubes of study gel in plastic bags with labelling indicating the order of dispensing ie Baseline-3 mths/3mths-6mths. Labelling will be performed by 2 staff who are not involved with the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomization schedule will be generated by the study statistician using the pseudo random number generator in Excel for Microsoft 365. Briefly a random number will be generated for each of the anticipated 16 participants within blocks of random even size. Within each block the participant order will be sorted by random number and those with smallest random numbers will be allocated to start active treatment first.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
2/06/2026
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment outside Australia
Country [1] 26778 0
New Zealand
State/province [1] 26778 0
Auckland

Funding & Sponsors
Funding source category [1] 318026 0
Commercial sector/Industry
Name [1] 318026 0
Medcryst Theraputics
Country [1] 318026 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Country
New Zealand
Secondary sponsor category [1] 320369 0
None
Name [1] 320369 0
Country [1] 320369 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316684 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 316684 0
Ethics committee country [1] 316684 0
New Zealand
Date submitted for ethics approval [1] 316684 0
20/12/2024
Approval date [1] 316684 0
06/05/2025
Ethics approval number [1] 316684 0
2025 FULL 21812

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 138658 0
Prof Nicola Dalbeth
Address 138658 0
University of Auckland, 22 Park Ave, Grafton, Auckland 1023
Country 138658 0
New Zealand
Phone 138658 0
+64 9232568
Email 138658 0
n.dalbeth@auckland.ac.nz
Contact person for public queries
Name 138659 0
Dr Anne Horne
Address 138659 0
University of Auckland, 22 Park Ave, Grafton, Auckland 1023
Country 138659 0
New Zealand
Phone 138659 0
+64 9239787
Email 138659 0
a.horne@auckland.ac.nz
Contact person for scientific queries
Name 138660 0
Nicola Dalbeth
Address 138660 0
University of Auckland, 22 Park Ave, Grafton, Auckland 1023
Country 138660 0
New Zealand
Phone 138660 0
+64 9232568
Email 138660 0
n.dalbeth@auckland.ac.nz

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: This is a commercial study and data sharing is the decision for the company funding the study.



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.