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Compares treatment options for Osteoarthritis Hand
Official title Capsaicin in Digital Osteoarthritis Versus Control
ClinicalTrials.gov ID: NCT06444919
What this study is testing
What is Capsaicin 179 Mg Cutaneous Patch?
Capsaicin 179 Mg Cutaneous Patch is an investigational medicine, given as an once-daily, being studied as a potential treatment for osteoarthritis hand.
Also referred to as QUTENZA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The objective of this multicentric, randomized controlled double-blind clinical trial is to demonstrate the efficacy of transdermal application of capsaicin in patients with painful digital osteoarthritis with a neuropathic pain component. Participants will receive either a transdermal patch of capsaicin 179 mg (8%) or the control treatment (capsaicin 0.04%).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of digital osteoarthritis fulfilling the American College of Rheumatology criteria;
- Presence of finger pain of ≥ 40 mm on a visual analogue scale (VAS);
- Presence of finger pain with a neuropathic pain component (DN4 score ≥ 4/10)
- Inadequate response, adverse reactions, and/or contraindications to conventional analgesics and NSAIDs;
You likely can't join if
- Patient with isolated rhizarthrosis;
- Patient with other joint disease affecting the fingers (gout, chondrocalcinosis, RA, spondyloarthritis, psoriatic arthritis);
- Patient with upper extremity pain syndrome that may interfere with the assessment of finger pain;
- Patient with another pathology responsible for neuropathic hand pain (carpal tunnel syndrome, diabetic neuropathy, Guyon's tunnel syndrome...
- Patient with skin lesions on the fingers (psoriasis, wounds, chronic ulcers, eczema, shingles, dermatitis);
- Patient with poorly controlled high blood pressure;
See the full eligibility criteria
- Diagnosis of digital osteoarthritis fulfilling the American College of Rheumatology criteria;
- Presence of finger pain of ≥ 40 mm on a visual analogue scale (VAS);
- Presence of finger pain with a neuropathic pain component (DN4 score ≥ 4/10)
- Inadequate response, adverse reactions, and/or contraindications to conventional analgesics and NSAIDs;
- Patient with isolated rhizarthrosis;
- Patient with other joint disease affecting the fingers (gout, chondrocalcinosis, RA, spondyloarthritis, psoriatic arthritis);
- Patient with upper extremity pain syndrome that may interfere with the assessment of finger pain;
- Patient with another pathology responsible for neuropathic hand pain (carpal tunnel syndrome, diabetic neuropathy, Guyon's tunnel syndrome, cervicobrachial neuralgia, brachial plexitis);
- Patient with skin lesions on the fingers (psoriasis, wounds, chronic ulcers, eczema, shingles, dermatitis);
- Patient with poorly controlled high blood pressure;
- Patient with hypersensitivity to capsaicin;
- Patient who had 8% capsaicin patch use in the year prior to the study;
- Patient who has received intramuscular, intra-articular or intravenous corticosteroid therapy, another disease-modifying anti-rheumatic therapy (methotrexate, salazopyrine) or an intra-articular injection into the...
- Patient wearing wrist or finger orthoses in the previous month;
- Patient with fibromyalgia;
The study team makes the final eligibility decision.
Where it's taking place
- Clermont-Ferrand, France
- Lyon, France
- Paris, France
- Saint-Etienne, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clermont-Ferrand, France; Lyon, France; Paris, France; Saint-Etienne, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.