None listed
Conditions
Brief summary
Gout is a common form of arthritis, caused by deposition of monosodium urate (MSU) crystals in the joints and surrounding tissues. These crystals can be dissolved with urate-lowering therapy, but crystal dissolution is often slow, particularly in people with tophaceous gout. This clinical trial will test the efficacy and safety of the MDCX101 Gel which is a topical therapy that may lead to more rapid dissolution of MSU crystals in people with gout. In the cross-over study participants with tophaceous gout will be randomized to either active treatment or placebo for the first three months, and then the other treatment for second three months. Dual energy CT scans will be used to measure the change MSU crystals after each treatment. The study hypothesis is that topical application of the MDCX101 Gel reduces monosodium urate (MSU) crystal deposits in people with tophaceous gout.
Interventions
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)
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.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed