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Trial registered on ANZCTR


Registration number
ACTRN12620000599976
Ethics application status
Approved
Date submitted
1/05/2020
Date registered
22/05/2020
Date last updated
22/05/2020
Date data sharing statement initially provided
22/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Topical corticosteroid for treatment of hand osteoarthritis
Scientific title
Topical corticosteroid for treatment of hand osteoarthritis
Secondary ID [1] 301177 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hand osteoarthritis 317309 0
Condition category
Condition code
Musculoskeletal 315428 315428 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Topical Diprosone OV (betamethasone dipropionate in Optimised Vehicle) ointment, one pea-sized amount per joint, 3 times per day to the study joints (defined as the hand joints with pain level of at least 30 on a 100 mm visual analogue scale as assessed at baseline) for 6 weeks.
The remaining ointment will be weighed at the end of the study to assess the adherence to the ointment.
Intervention code [1] 317482 0
Treatment: Drugs
Comparator / control treatment
Plain paraffin ointment 3 times per day to the study joints for 6 weeks.
Plain paraffin ointment will be provided in the same packaging as Topical Diprosone OV, and the paraffin ointment is the same in appearance and similar in smell as the intervention.
Control group
Placebo

Outcomes
Primary outcome [1] 323677 0
Change in pain assessed using visual analogue scale
Timepoint [1] 323677 0
6 weeks after intervention commencement
Secondary outcome [1] 382554 0
Change in hand pain and function, assessed using Functional Index for Hand Osteoarthritis
Timepoint [1] 382554 0
6 weeks after intervention commencement
Secondary outcome [2] 382555 0
Change in hand pain and function, assessed using Australian Canadian Osteoarthritis Hand Index
Timepoint [2] 382555 0
6 weeks after intervention commencement
Secondary outcome [3] 382556 0
Change in hand pain and function, assessed using Michigan Hand Outcomes Questionnaire
Timepoint [3] 382556 0
6 weeks after intervention commencement
Secondary outcome [4] 382557 0
Change in tender and swollen joint count assessed using the tender and swollen score
Timepoint [4] 382557 0
6 weeks after intervention commencement
Secondary outcome [5] 382558 0
Change in grip strength assessed using hand dynamometer
Timepoint [5] 382558 0
6 weeks after intervention commencement

Eligibility
Key inclusion criteria
1. Participants aged >40 years with symptomatic radiological hand osteoarthritis;
2. Pain score of at least 40 on a 100 mm visual analogue scale and radiological OA (Kellgren and Lawrence grade >=2) in >=1 joint;
3. Stable analgesic requirements (including non-steroidal anti-inflammatory drugs) for at least 4 weeks, stable doses of chondroitin or glucosamine for 4 months, no corticosteroids via any route for at least 3 months.
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Concomitant rheumatic disease, inflammatory joint disease, psoriatic arthritis, ankylosing spondylitis, or gout;
2. Allergic reaction to other medicines containing betamethasone dipropionate, any other corticosteroid(s), or any of the ingredients of Diprosone OV ointment (i.e. betamethasone as dipropionate, propylene glycol, white beeswax, propylene glycol monostearate, and soft white paraffin);
3. Contraindication to topical corticosteroids (e.g. untreated bacterial, fungal, or viral skin lesions; widespread plaque psoriasis; skin conditions with ulcers);
4. Unable to complete informed consent;
5. Pregnancy, breast feeding, or trying to become pregnant.

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)
Allocation of participants in a 1:1 ratio to one of the two groups will be based on computer generated random numbers prepared by a statistician with no involvement in the trial. Block randomization will be performed, stratified according to gender
Methods used to generate the sequence in which subjects will be randomised (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
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 305627 0
University
Name [1] 305627 0
Monash University
Address [1] 305627 0
School of Public Health and Preventive Medicine
Monash University
553 St Kilda Road
Melbourne VIC 3004
Country [1] 305627 0
Australia
Primary sponsor type
Individual
Name
Flavia Cicuttini
Address
School of Public Health and Preventive Medicine
Monash University
553 St Kilda Road
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 306032 0
Individual
Name [1] 306032 0
Yuanyuan Wang
Address [1] 306032 0
School of Public Health and Preventive Medicine
Monash University
553 St Kilda Road
Melbourne VIC 3004
Country [1] 306032 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305915 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 305915 0
Office of Ethics & Research Governance
Level 5, 553 St Kilda Road
Melbourne, VIC 3004
Ethics committee country [1] 305915 0
Australia
Date submitted for ethics approval [1] 305915 0
Approval date [1] 305915 0
03/04/2020
Ethics approval number [1] 305915 0
Ethics committee name [2] 305916 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 305916 0
Room 116, Level 1
Chancellery Building D
26 Sports Walk, Clayton Campus
Wellington Road
Clayton VIC 3800
Ethics committee country [2] 305916 0
Australia
Date submitted for ethics approval [2] 305916 0
Approval date [2] 305916 0
17/04/2020
Ethics approval number [2] 305916 0

Summary
Brief summary
Aim: To assess, using a parallel-group randomized controlled design, the effect of topical Diprosone OV ointment administered 3 times daily compared to placebo in reducing pain and improving function in participants with hand osteoarthritis over 6 weeks.
Hypothesis: Topical Diprosone OV ointment administered 3 times daily would be more effective than placebo in reducing pain (visual analogue scale) and improving function (assessed using validated questionnaires and grip strength) in participants with hand osteoarthritis over 6 weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102050 0
Prof Flavia Cicuttini
Address 102050 0
School of Public Health and Preventive Medicine
Monash University
553 St Kilda Road
Melbourne VIC 3004
Country 102050 0
Australia
Phone 102050 0
+61 3 9903 0158
Fax 102050 0
Email 102050 0
flavia.cicuttini@monash.edu
Contact person for public queries
Name 102051 0
Prof Flavia Cicuttini
Address 102051 0
School of Public Health and Preventive Medicine
Monash University
553 St Kilda Road
Melbourne VIC 3004
Country 102051 0
Australia
Phone 102051 0
+61 3 9903 0158
Fax 102051 0
Email 102051 0
flavia.cicuttini@monash.edu
Contact person for scientific queries
Name 102052 0
Dr Yuanyuan Wang
Address 102052 0
School of Public Health and Preventive Medicine
Monash University
553 St Kilda Road
Melbourne VIC 3004
Country 102052 0
Australia
Phone 102052 0
+61 3 99030353
Fax 102052 0
Email 102052 0
yuanyuan.wang@monash.edu

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 other documents available
Summary results
No Results