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A study to evaluate the effect of topical clobetasol propionate versus a placebo for the treatment of inflammatory hand osteoarthritis in adults.

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals living with Hand Osteoarthritis, which is a condition involving the breakdown of protective tissue in the joints of the hands, often accompanied by inflammation or swelling. The research aims to compare the effectiveness of a topical medication called clobetasol propionate against a placebo in reducing the intensity of pain caused by this condition.

The treatment involves applying clobetasol propionate directly to the skin of the hands. Participants in the study will follow a specific schedule where the medication is used twice a day for the first two weeks, followed by a period of using it once a day for the next two weeks. This approach is known as a tapering regimen, which means the amount or frequency of the medication is gradually reduced over time.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>treatment initiation</b>

    You will receive either clobetasol propionate, which is a medication applied to the skin, or a placebo, which is an inactive substance used for comparison.

  2. Step 2

    <b>first phase of application</b>

    For the first 2 weeks, the medication or placebo is applied to the skin twice daily.

  3. Step 3

    <b>second phase of application</b>

    For the following 2 weeks, the frequency of application is reduced to once daily.

  4. Step 4

    <b>pain assessment</b>

    At the start of the trial and again at the end of week 4, you will report the amount of hand pain experienced during the previous 48 hours using a 100 mm scale.

Who can join the trial?

9 criteria

  • You must be at least 45 years old.
  • You must have hand osteoarthritis, which is a type of joint wear and tear that causes swelling and pain, specifically meeting certain medical standards.
  • Your pain level must be rated at 40 out of 100 or higher on a visual scale (called EVA, which is a tool used to measure how much pain you feel) within the last 48 hours.
  • You must have experienced hand pain for at least 15 days during the last month.
  • You must have at least two interphalangeal (IP) joints, which are the joints in your fingers, that show signs of synovitis, meaning there is visible swelling of the joint lining.
  • An ultrasound (a medical imaging test using sound waves) must show moderate or major inflammation or a Power Doppler signal, which is a way to see increased blood flow caused by inflammation, in at least two finger joints.
  • You must provide written informed consent, which means you formally agree to participate after understanding the study details.
  • You must be covered by a social security scheme (a type of health insurance or government healthcare system).
  • You must have already tried and failed to find relief from at least one standard treatment, such as paracetamol (a common pain reliever), NSAIDs (medicines that reduce inflammation and pain, taken as creams or pills), or a short course of corticosteroids (medicines used to reduce swelling).

Who cannot join the trial?

21 criteria

  • People who have pain only at the base of the thumb, which is the joint where the thumb meets the wrist.
  • People who have started any new treatment for hand osteoarthritis (wear and tear of the joints) in the last 2 months, such as physiotherapy (physical exercises) or getting a new hand splint (a support device for the hand).
  • People who have used opioids (strong pain-relieving medicines) in the last 4 weeks.
  • People who are planning to have hand surgery in the next 6 weeks.
  • People who have used any investigational drugs (medicines that are still being tested and are not yet approved for general use) in the last 3 months.
  • People with a history of glaucoma (a condition that causes high pressure in the eye and can damage vision) that prevents them from using corticosteroids (medicines that reduce swelling and inflammation).
  • People with serious, uncontrolled problems with their cardiovascular (heart and blood vessels), pulmonary (lungs), renal (kidneys), hepatic (liver), endocrine (hormones), gastrointestinal (stomach and intestines), or neurological (brain and nerves, such as epilepsy) systems.
  • People with a systemic progressive infection (an infection that is spreading throughout the entire body).
  • Women who are pregnant or breastfeeding.
  • People who are under legal protection (such as having a legal guardian) or those who are not free to leave.
  • People who are unable to physically apply the medicine to their own hands.
  • People with other types of inflammatory joint diseases, such as gout, rheumatoid arthritis, or Lyme disease.
  • People currently taking part in another medical study or those who have just finished a different study too recently.
  • People who receive state medical aid (government-funded healthcare).
  • People with any skin abnormalities, irritation, or lesions (sores or wounds) on their hands, such as eczema (itchy, red skin) or skin infections, that would make it unsafe to put cream on the skin.
  • People who are allergic to or cannot use clobetasol propionate (the specific medicine being studied).
  • People with a pain syndrome in the arms that would make it difficult for doctors to accurately measure their pain levels.
  • People with fibromyalgia (a condition that causes widespread muscle pain and tiredness).
  • People who have used steroids (inflammation-reducing medicine) by mouth, through a muscle, into a joint, or through a vein, or used anti-rheumatic drugs (medicines used to treat arthritis) in the last month.
  • People who have taken oral NSAIDs (common painkillers like ibuprofen) or paracetamol less than 48 hours before the study begins.
  • People who have used any topical treatment (creams or ointments applied to the skin) on their arms or hands in the last 2 weeks, except for standard cosmetic lotions.
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Investigated drugs

Clobetasol propionate is a strong cream applied directly to the skin. In this study, it is being tested to see if it can help reduce pain caused by inflammation in the hands.

What is already known about the treatment

  • Clobetasol propionate

    This medication is a strong corticosteroid applied directly to the skin to treat various inflammatory skin conditions. In this study, it is used to help reduce swelling and pain caused by inflammation in the hands. At a molecular level, it works by calming down the body's immune response and reducing the production of chemicals that cause redness and swelling. It belongs to a class of drugs known as topical corticosteroids.

  • Placebo

    This is an inactive substance that looks like the real medication but contains no active medicine. It is used in clinical research as a control to help scientists determine if the actual drug is truly effective. It does not have a specific therapeutic purpose or a molecular mechanism of action. In this trial, it is administered in the same way as the test medication to ensure a fair comparison.

Investigated diseases

Hand osteoarthritis - This condition involves the gradual breakdown of the protective cartilage that cushions the joints in the hands. As the cartilage wears away, the bones may begin to rub against each other, leading to discomfort. Inflammation can occur in the joint lining, causing swelling and tenderness. Over time, the disease can cause the joints to become stiff and less flexible. It may also lead to the formation of small bony growths around the affected joints.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520678-20-00Protocol codeAPHP240804Estimated enrolment187 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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