Capsaicin 179 Mg Cutaneous Patch
Drugpatch application for 30 minutes on the painful fingers.
Other names: QUTENZA
NCT Number: NCT06444919
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)
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
CHU de Clermont-Ferrand, Clermont-Ferrand, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
patch application for 30 minutes on the painful fingers.
Other names: QUTENZA
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).
Other names: control treatment
Time frame: Day 60
measured on a visual analogic scale ranging from 0 to 100 mm
Time frame: Day 60
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.
Time frame: Day 60
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.
Time frame: Day 60
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.
Time frame: Day 60
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.
Time frame: Day 60
side effect rate
Time frame: Day 60
Patient Global Impression of Change " (PGIC) score. The patient evaluates the degree of improvement of his pain
Contact information is provided by the study sponsor or research team.
University Hospital, Clermont-Ferrand
Other
Capsaicin in Digital Osteoarthritis Versus Control : a Randomized Study
Acronym: CADOR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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