Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch for the Treatment of Chronic Postsurgical or Post-traumatic Neuropathic Pain: a Randomized Placebo Controlled Study in Children Aged 12 to 17-y

29BRC21.0184

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).

2024-03-05

2026-04-05

2026-04-05

Recruiting

Early phase I

46

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicentric randomized controlled superiority trial in parallel arms:\n\n* experimental arm : Capsaicin 8% cutaneous patch\n* control arm : Hydrocolloid dressing', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'There is no mock cutaneous patch available for capsaicin 8% cutaneous patch. So we have chosen hydrocolloid dressing for placebo since it has no known effect on neuropathic pain and the tolerability is expected as excellent.\n\nThe patient should not be aware of the specific aspect of capsaicin 8% patch and the protocol of application will be exactly the same. This should keep the patient blinded for the study treatment.\n\nThe nurse who applies the patch is unblinded.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 46, 'type': 'ESTIMATED'}}

2024-03-21