NCT06444919

Capsaicin in Digital Osteoarthritis Versus Control

Capsaicin in Digital Osteoarthritis Versus Control : a Randomized Study

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

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.

Conditions

• Osteoarthritis Hand
• Neuropathic Pain

Interventions

Type	Name	Description
DRUG	Capsaicin 179 Mg Cutaneous Patch	patch application for 30 minutes on the painful fingers.
DRUG	Capsaicine low dose 0.04 %	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).

Timeline

• Start date: 2025-03-07
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2024-06-06
• Last updated: 2025-03-13

Locations

4 sites across 1 country: France