NCT05997979 Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children
| NCT ID | NCT05997979 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Hospital, Brest |
| Condition | Neuropathic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2024-03-05 |
| Primary Completion | 2028-07-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 46 participants in total. It began in 2024-03-05 with a primary completion date of 2028-07-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study concerns children aged to 12 to 17-years with local chronic neuropathic pain after trauma or surgery. It is a multicentric randomized controlled superiority trial in parallel arms : * experimental arm: Capsaicin 8% cutaneous patch * controlled arm : Hydrocolloid dressing Treatment with capsaicin application is realized at baseline, and repeated 3 months after the first patch application if needed. Tolerance is assessed during each application and by phone call in following days until stop of cold need. Efficacy is assessed monthly by clinical consultation until the end of the study (month 4).
Eligibility Criteria
Inclusion Criteria: * Children aged 12 to 17 years (lower age limit of 12 has been chosen to ensure NPSI full filling). * Male or female. * Persistent neuropathic pain more than 3 months after surgery or trauma despite treatment following recommendations. * Neuropathic pain is defined as a DN4 score equal to or greater than 3/7 or 4/10, and localized in a nerve territory explained by the surgery or the trauma. * Treatment, survey and follow up must be realized in an identified investigating center of the study * For patients of childbearing potential: use of an adequate method of contraception\* during the course of the study through 48 hours after the last patch application (girls of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to the first patch application). * Adequate contraception includes sexual abstinence, progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide, combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods) Exclusion Criteria: * Intellectual deficiency not allowing full filling of NPSI. * Insufficient command of the French language to full fill NPSI and other evaluation tools. * Parents' refusal of consent. * Minor patients' opposition. * Underlying neurological disease. * Ongoing neurotoxic treatment. * Already treated by capsaicin. * Cutaneous lesion on pain area. * Patient presenting a pain area on the face, above the hairline of the scalp, and/or in proximity to mucous membranes * Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of Qutenza SmPC.
Contact & Investigator
Philippe J LE MOINE, MD
PRINCIPAL INVESTIGATOR
CHU of Brest
Frequently Asked Questions
Who can join the NCT05997979 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 17 Years, studying Neuropathic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05997979 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 46 participants.
Is NCT05997979 currently recruiting?
Yes, NCT05997979 is actively recruiting participants. Contact the research team at philippe.lemoine@chu-brest.fr for enrollment information.
Where is the NCT05997979 trial being conducted?
This trial is being conducted at Amiens, France, Angers, France, Bordeaux, France, Brest, France and 6 additional locations.
Who is sponsoring the NCT05997979 clinical trial?
NCT05997979 is sponsored by University Hospital, Brest. The principal investigator is Philippe J LE MOINE, MD at CHU of Brest. The trial plans to enroll 46 participants.