Topical Clobetasol Propionate for Inflammatory Hand osteoarthritis: A randomized trial versus placebo.(PROCLAME)
Osteoarthritis in the hands can cause painful, stiff, and swollen joints, making everyday tasks difficult. This clinical trial, named PROCLAME, is looking at whether applying a strong anti-inflammatory steroid cream (clobetasol propionate) directly to the skin over painful hand joints can ease these symptoms. Participants will be randomly placed into one of two groups. One group will use the medicated cream, while the other group will use a matching dummy (placebo) cream that contains no active medicine. The trial lasts for four weeks. Researchers will track changes in hand pain over the previous 48 hours, as well as changes in joint stiffness, daily hand function, and overall quality of life. The main goal is to find out if this simple, skin-applied treatment is an effective way to relieve inflammatory hand arthritis.
At a glance
What is this study about?
Hand osteoarthritis is a common condition that affects the joints in the fingers and thumbs. Over time, the smooth cartilage protecting the bones can wear down. In many people, this leads to painful flare-ups with swelling, heat, and morning stiffness, making simple tasks like opening jars, writing, or turning keys quite difficult.
Steroids are powerful medicines that reduce swelling and pain. They are often given as pills or direct joint injections, but pills can cause side effects across the whole body, and injections into small finger joints can be uncomfortable. In this study, researchers are testing clobetasol propionate, a steroid cream usually used for skin conditions, to see if applying it straight onto the skin over the joints can calm down local inflammation.
Because this is a Phase 3 trial, it is one of the final stages of research to prove whether the treatment works well and is safe. By comparing the steroid cream to an inactive dummy cream, researchers hope to discover a simple, targeted treatment that gives people with painful hand osteoarthritis better relief and improves their daily quality of life.
Key takeaways
- Testing whether a steroid skin cream relieves painful, swollen hand osteoarthritis.
- A four-week study comparing the active cream against an inactive dummy cream.
- Aimed at adults aged 18 and older with active, painful hand joint symptoms.
- Measures improvements in pain, morning stiffness, daily hand tasks, and well-being.
- Participation is voluntary, and you can leave the study at any time.
Who may be eligible?
This study is open to adults aged 18 and over who have been diagnosed with hand osteoarthritis. To take part, your arthritis must be causing noticeable, active symptoms such as joint pain and signs of inflammation like swelling or warmth in your hands.
Both men and women can join. Because the study measures how pain changes over time, participants will need to have had regular hand pain in the days leading up to the study.
People might not be able to join if their hand pain is caused by a different type of arthritis (such as rheumatoid arthritis), if they have skin conditions on their hands that could react poorly to steroid creams, or if they have recently received certain other joint treatments. A study doctor will check all medical details to make sure taking part is safe.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have been diagnosed with osteoarthritis in my hands.
- My hands are currently painful, stiff, or visibly swollen.
- I am able and willing to apply a cream to my hands for four weeks.
- I can attend clinic visits and answer questions about my joint pain.
What does participation involve?
Taking part in the study lasts for four weeks. At the start (Week 0), you will have an initial visit with the research team to review your medical history, check your joints, and complete a baseline score of your hand pain over the last 48 hours.
You will be given a cream to apply to your painful hand joints as directed by the team. You will have an equal chance of receiving either the active clobetasol propionate cream or a dummy cream with no active drug. Neither you nor the study team will know which one you are using until the study is over.
During the four weeks, you may be asked to keep a simple diary of your symptoms. At the end of Week 4, you will complete follow-up assessments to rate your pain, stiffness, how easily you can use your hands, and your overall well-being. Once these checks are finished, your time in the trial is complete.
Potential risks and benefits
Locations (1)
- —UnverifiedFrance
Common questions
What is clobetasol propionate?
It is a well-known, strong steroid medicine applied to the skin. It works by reducing swelling, redness, and inflammation.
What is a placebo?
A placebo is an inactive dummy treatment that looks and feels just like the real medicine but contains no active ingredients. It helps researchers prove whether the real drug truly makes a difference.
Will I definitely receive the medicated cream?
No. Participants are placed into treatment groups at random by a computer, meaning you have an equal chance of receiving the active steroid cream or the placebo cream.
How long does the study last?
The study treatment and monitoring period lasts for four weeks from your first assessment.
Can I leave the study if I change my mind?
Yes. Taking part is completely voluntary, and you can stop at any time without giving a reason and without affecting your normal healthcare.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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