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Trial registered on ANZCTR


Registration number
ACTRN12622000111774
Ethics application status
Approved
Date submitted
22/12/2021
Date registered
24/01/2022
Date last updated
24/01/2022
Date data sharing statement initially provided
24/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Online clinical trial on a novel topical gel for hand osteoarthritis pain
Scientific title
Evaluation of a novel topical gel for hand osteoarthritis pain: An exploratory trial
Secondary ID [1] 306084 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hand osteoarthritis 324773 0
Condition category
Condition code
Musculoskeletal 322223 322223 0 0
Osteoarthritis
Anaesthesiology 322342 322342 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: The test product is a TGA-approved (ARTG ID: 317968) pain-relief cream, Soodox Active, developed by Eczanes Pharmaceuticals Pty Ltd. The product will be dispensed in one 25g tube per participant for home application. It's active ingredients include: arnica extract, rosemary oil, clove bud oil, emu oil.
˜2cm of the product will be applied topically on the hands 4 times p/day for 7 days

Participant compliance to the treatment instructions will be assess objectively by weighing the tubes of gels prior to supply and at the end of treatment. Compliance will be measured subjectively when participants self-report each application time.
Intervention code [1] 322519 0
Treatment: Drugs
Comparator / control treatment
The TGA-approved musculoskeletal pain gel, Voltaren Emulgel, will be used as the active comparator against the test product (ARTG ID: 47676). It's main active ingredient is diclofenac.
˜2cm of the product will be applied topically on the hands 4 times p/day for 7 days
Control group
Active

Outcomes
Primary outcome [1] 329990 0
Pain (Visual Analogue Scale)
Timepoint [1] 329990 0
Before + After breakfast each day
Average pain from days 1-3
Average pain from days 4-7
Primary outcome [2] 329991 0
Pain (Visual Analogue Scale)
Timepoint [2] 329991 0
Between-groups difference in pain intensity change from pre-application at baseline to 60 minutes after the day 7 application.
Secondary outcome [1] 404531 0
Quality of life (5 level & dimensional EQoL)
Timepoint [1] 404531 0
Baseline to day 7. This will be measured once at baseline and once more on Day 7.
Secondary outcome [2] 404532 0
Hand function (AUSCAN)
Timepoint [2] 404532 0
Baseline to day 7. This will be measured once at baseline and once more on Day 7.
Secondary outcome [3] 404901 0
Hand Function (AIMS2)
Timepoint [3] 404901 0
Baseline to day 7. This will be measured once at baseline and once more on Day 7.

Eligibility
Key inclusion criteria
1. Adults of any age over 18 years.
2. Have been diagnosed with hand osteoarthritis
3. Have at least two inter/distal phalangeal and/or one first carpometacarpal joint pain
4. Have at least two or three painful flare-ups of pain in a finger joint during the previous 12 months
5. Discontinuation of all analgesic (prescription or over the counter) at least 3 days prior to first application.
6. Able and willing to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Allergies to NSAIDs or any of either of the gel’s ingredients
2. Inflamed or broken skin in area to be treated
3. Signs or symptoms of systemic infection (such as fever, and chills, nausea and vomiting, blotchy or discoloured skin, weakness, or diarrhoea) as this is not indicated for local osteoarthritis pain
4. Systemic conditions (i.e. rheumatoid arthritis, Buerger’s disease, mucous cyst, dactylitis, pyogenic granuloma) and/or taking anti-rheumatic drugs (i.e. methotrexate, cyclosporine)
5. Autoimmune diseases: lupus, multiple sclerosis
6. Have chronic kidney disease/acute kidney injury
7. Use of non-prescription topical or oral analgesic treatment within the last 48 hours
8. Current use of a prescription topical or oral analgesic treatment and unable to stop this for the duration of the trial
9. History of stomach ulcers
10. Asthma
11. Anticoagulation/antithrombotic therapies such as aspirin and warfarin
12. Antidepressant therapies such as Sertraline (Zoloft), citalopram, fluoxetine and paroxetine
13. Taking blood pressure medications
14. Acute injury or trauma to either hand in the previous 2 months
15. Anyone with loss of sensation in their hands
16. Pregnancy
17. Scheduled surgery within 2 weeks as there may be a low risk for post-operative bleeding.

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)
The principle investigator determining eligibility will be unaware of which group the subject will be allocated to. Participants will be allocated to either the test (Soodox Active) or control (Voltaren Emulgel) group in a 1:1 ratio using a predetermined, computer-generated randomisation schedule performed by an independent trial technician (Research Assistant, Ms Rowan Adams), who will not otherwise be directly involved in the study.

The allocation sequence will be concealed throughout the study and researchers will not see the gel being used by the participant. The randomisation schedule will be kept secure (password-protected) by the trial technician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
The gels will be packaged in identical tubes to maintain blinding of the participants, and marked with the participant number, safety information and application instructions. There are differences in smell and consistency between the two gels. Therefore, the participants cannot be considered fully blinded.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A statistical analysis plan will be developed by the trial statistician and approved by all investigators prior to data collection. The trial statistician will be blinded to treatment allocation. The treatment effect size for the primary outcome measure will be determined via a statistical model. The effect size will be presented as the difference in means between the within-group changes in the intervention and active comparator group. Differences between the groups will be presented with a 95% confidence interval to describe the uncertainty/precision associated with the intervention effect estimate.

A mixed linear model will be used to determine the average effect of treatment and time, and difference between treatments on effect of time while controlling for between-subject variability. The loss to follow-up will be calculated by dividing the number of participants in the analysis on Day 7 by the number of participants originally randomised. Subjects who withdraw prior to Day 7 will be dropped in the analysis. The Consolidated Standards of Reporting Trial (CONSORT) guidelines will be used to report the numbers of participants randomised, received intended treatment, and analysed for the primary outcome.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/02/2022
Actual
Date of last participant enrolment
Anticipated
1/06/2022
Actual
Date of last data collection
Anticipated
20/06/2022
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 310458 0
Commercial sector/Industry
Name [1] 310458 0
Eczanes Pharmaceuticals Pty Ltd providing in-kind support
Country [1] 310458 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
11 Kirinari St, Bruce ACT 2617
Country
Australia
Secondary sponsor category [1] 311604 0
None
Name [1] 311604 0
None
Address [1] 311604 0
None
Country [1] 311604 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310065 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 310065 0
Ethics committee country [1] 310065 0
Australia
Date submitted for ethics approval [1] 310065 0
20/08/2021
Approval date [1] 310065 0
15/12/2021
Ethics approval number [1] 310065 0
20219193

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

Contacts
Principal investigator
Name 116370 0
Mr Andrew Chen
Address 116370 0
University of Canberra address: 11 Kirinari St, Bruce ACT 2617
Country 116370 0
Australia
Phone 116370 0
+61 402722436
Fax 116370 0
Email 116370 0
u3203042@uni.canberra.edu.au
Contact person for public queries
Name 116371 0
Andrew Chen
Address 116371 0
University of Canberra address: 11 Kirinari St, Bruce ACT 2617
Country 116371 0
Australia
Phone 116371 0
+61 402722436
Fax 116371 0
Email 116371 0
u3203042@uni.canberra.edu.au
Contact person for scientific queries
Name 116372 0
Andrew Chen
Address 116372 0
University of Canberra address: 11 Kirinari St, Bruce ACT 2617
Country 116372 0
Australia
Phone 116372 0
+61 402722436
Fax 116372 0
Email 116372 0
u3203042@uni.canberra.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.