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AzTrials

Osteoarthritis HandPhase 4CADORNCT06444919

Capsaicin in Digital Osteoarthritis Versus Control

A Phase 4 study testing Capsaicin 179 Mg Cutaneous Patch and Capsaicine low dose 0.04 % in people with Osteoarthritis Hand and Neuropathic Pain, run by University Hospital, Clermont-Ferrand at 4 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis Hand, Neuropathic Pain
What is being tested?
Capsaicin 179 Mg Cutaneous Patch and Capsaicine low dose 0.04 %
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
4 sitesFrance
Study dates
7 Mar 2025to 1 Jan 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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;
Show all 11Show fewer
  • 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 joints of the fingers within the previous 3 months;
  • Patient wearing wrist or finger orthoses in the previous month;
  • Patient with fibromyalgia;

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lise Laclautre contact

334.73.754.963

promo_interne_drci@chu-clermontferrand.fr

France4 sites, 4 recruiting

  • CHU de Clermont-Ferrand

    Clermont-Ferrand

    Lise Laclautre

    Sylvain Mathieu

    Recruiting

  • HCL Hôpital Edouard Herriot

    Lyon

    Lise Laclautre

    Roland CHAPURLAT

    Recruiting

  • AP-HP Hôpital Saint-Antoine

    Paris

    Lise Laclautre

    Jérémie SELLAM

    Recruiting

  • CHU de Saint-Etienne

    Saint-Etienne

    Lise Laclautre

    Thierry Thomas

    Recruiting

Other trials in France

About this study

Official title: Capsaicin in Digital Osteoarthritis Versus Control : a Randomized Study

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%).

Researchers will compare the intensity of pain in the fingers at day 60 in the capsaicin 8% group versus capsaicin 0.04% (control arm)

Read the detailed description

Visit 0 : Screening visit (D0 - 30 days): Screen for eligibility

Visit 1 :Inclusion visit (D0): Randomization and blinded patch application of capsaicin 8% or 0.04%

Visit 2: Follow-up visit 1 (D60 + 7 days): Assessment +/- Patch renewal. Patients with finger pain still greater than 4/10 may receive an open application of a capsaicin 8%

Visit 3:Follow-up visit 2 (D120 +/- 7 days): Final assessment.

For the duration of the study, the patient will record in a notebook: analgesics, anti-inflammatories, corticoids and daily hand pain VAS.

Blood samples will be taken at V1 and V2 for subsequent measurement of pro-inflammatory cytokines (IL6, IL8, TNFa) and markers of cartilage degradation, in order to build up a serum library.

Being tested
Capsaicin 179 Mg Cutaneous Patch, Capsaicine low dose 0.04 %
Medical subject headings
Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Capsaicin 179 Mg Cutaneous PatchDrug

    Also called QUTENZA

    patch application for 30 minutes on the painful fingers.

  • Capsaicine low dose 0.04 %Drug

    Also called control treatment

    patch application for 30 minutes on the painful fingers. the low-dose patch has a similar appearance to the active patch. It allows you to keep the blind, because it also causes reactions at the capsaicin application site (erythema, burning).

Study groups in NCT06444919
Study groupRoleWhat they receive
Capsaicin 8%Experimentalpatch 179 mg, 30 min
Receives: Drug: Capsaicin 179 Mg Cutaneous Patch
Capsaicin 0.04%Sham comparatorpatch low dose, 30 min
Receives: Drug: Capsaicine low dose 0.04 %

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intensity of pain in the fingers

    measured on a visual analogic scale ranging from 0 to 100 mm

    Measured: Day 60

Secondary outcomes (6)

  1. Functional disability

    Cochin Hand Functional Disability Scale score, Each question is rated from 0 (no difficulty) to 5 (impossible). Total score for 18 questions: 0 - 90. The higher the score, the more impaired the physical function.

    Measured: Day 60

  2. Functional index

    Modified Functional Index for Hand OsteoArthritis score (FIHOA), Each question is rated from 0 (no difficulty) to 3 (impossible). Total score for the 10 questions: 0 - 30. The higher the score, the greater the functional disability.

    Measured: Day 60

  3. Anxiety and depression

    Hospital Anxiety and Depression Scale score (HADs), Each question is scored from 0 to 3. Total score for the 7 anxiety or depression questions: 0-21. The higher the score, the more anxious or depressed the patient.

    Measured: Day 60

  4. Painful symptoms of osteoarthritis

    Osteoarthritis Symptom Inventory Scale score (OASIS9). Localized pain component = 4 questions rated from 0 (no sensation) to 10 (extreme sensation) score = 0-40.

    Neuropathic pain component = 2 questions rated from 0 to 10 score = 0-20. Deep pain component = 3 questions rated from 0 to 10 score = 0-30. Total OASIS score: 0-90. A high score indicates intense pain.

    Measured: Day 60

  5. Treatment safety

    side effect rate

    Measured: Day 60

  6. Patient impression of change

    Patient Global Impression of Change " (PGIC) score. The patient evaluates the degree of improvement of his pain

    1. - Strongly improved
    2. - Moderately improved
    3. - Slightly improved
    4. - No change
    5. - Slightly worsened
    6. - Moderately worsened
    7. - Strongly worsened

    Measured: Day 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2024
  2. Study start7 Mar 2025 (estimated)
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion1 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06444919
Sponsor's protocol ID
PHRC IR 2022 MATHIEU
Other IDs
2024-511159-16-00
Acronym
CADOR
Status last verified
Feb 2025
First submitted
31 May 2024
Last updated
13 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fan A, Lambert C, Sellam J, Chapurlat R, Marotte H, Pereira B, Thomas T, Tournadre A, Soubrier M, Mathieu S. CADOR (Capsaicin in neuropathic-like pain in digital osteoarthritis) study protocol: a multicentre randomised parallel-group trial. BMJ Open. 2025 Mar 6;15(3):e093409. doi: 10.1136/bmjopen-2024-093409.

    PubMed 40050054

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Capsaicin 179 Mg Cutaneous Patch and Capsaicine low dose 0.04 % in people with Osteoarthritis Hand and Neuropathic Pain, run by University Hospital, Clermont-Ferrand at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intensity of pain in the fingers (time frame: Day 60). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06444919, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.

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