Capsaicin in Digital Osteoarthritis Versus Control

NCT06444919 | Recruiting Phase 4

• 2 other identifiers: PHRC IR 2022 MATHIEU2024-511159-16-00
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief 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. 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)

Conditions

Osteoarthritis Hand; Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Intensity of pain in the fingers

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

  Day 60

Secondary Outcomes (6)

• Functional disability

  Day 60

• Functional index

  Day 60

• Anxiety and depression

  Day 60

• Painful symptoms of osteoarthritis

  Day 60

• Treatment safety

  Day 60

Study Arms (2)

Capsaicin 8%

EXPERIMENTAL

patch 179 mg, 30 min

Drug: Capsaicin 179 Mg Cutaneous Patch

Capsaicin 0.04%

SHAM COMPARATOR

patch low dose, 30 min

Drug: Capsaicine low dose 0.04 %

Interventions

Capsaicin 179 Mg Cutaneous Patch DRUG

patch application for 30 minutes on the painful fingers.

Also known as: QUTENZA

Capsaicin 8%

Capsaicine low dose 0.04 % DRUG

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).

Also known as: control treatment

Capsaicin 0.04%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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, 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 joints of the fingers within the previous 3 months;
• Patient wearing wrist or finger orthoses in the previous month;
• Patient with fibromyalgia;

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Grünenthal GmbH: collaborator

Study Sites (4)

CHU de Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

HCL Hôpital Edouard Herriot

Lyon, France

RECRUITING

AP-HP Hôpital Saint-Antoine

Paris, France

RECRUITING

CHU de Saint-Etienne

Saint-Etienne, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 40050054 DERIVED

MeSH Terms

Conditions

Neuralgia

Interventions

Capsaicin; Transdermal Patch

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Equipment and Supplies

Study Officials

• Sylvain Mathieu

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 6, 2024
• Study Start: March 7, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)