Capsaicin patch for treating chronic pain in children

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

This study is testing if a special capsaicin patch can help relieve chronic pain in kids aged 12 to 17 who have pain after an injury or surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 12 Years to 17 Years
• Sex: All
• Sponsor: University Hospital, Brest (Academic / other)
• Locations: 10 sites (Amiens and 9 other locations)
• Trial ID: NCT05997979 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of a Capsaicin 8% cutaneous patch in children aged 12 to 17 years suffering from local chronic neuropathic pain following trauma or surgery. It is a multicentric randomized controlled trial with two arms: one receiving the capsaicin patch and the other receiving a hydrocolloid dressing as a control. The treatment is administered at baseline and may be repeated after three months if necessary. Tolerance and efficacy are monitored through clinical consultations and follow-up calls over a four-month period.

Who should consider this trial

Good fit: Ideal candidates are children aged 12 to 17 years with persistent neuropathic pain lasting more than two months after trauma or surgery.

Not a fit: Patients with mild pain not requiring oral treatment or those without neuropathic pain may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant pain relief for children suffering from chronic neuropathic pain.

How similar studies have performed: Other studies have shown promise in using capsaicin for pain management, suggesting potential success for this approach.

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.

Where this trial is running

Amiens and 9 other locations

• CHU d'Amiens — Amiens, France (Recruiting)
• CHU d'Angers — Angers, France (Recruiting)
• CHU de Bordeaux — Bordeaux, France (Recruiting)
• CHU de Brest — Brest, France (Recruiting)
• CHU de Nantes — Brest, France (Recruiting)
• CHU de Lyon — Lyon, France (Recruiting)
• CHU de Marseille — Marseille, France (Recruiting)
• CHU de Montpellier — Montpellier, France (Recruiting)
• CHU de Tours — Tours, France (Recruiting)
• Institut Gustave Roussy — Villejuif, France (Recruiting)

Study contacts

• Principal investigator: Philippe J LE MOINE, MD — CHU of Brest
• Study coordinator: Philippe J LE MOINE, MD

Conditions Neuropathic Pain; Chronic Pain; Pediatric; Capsaicin; Randomized clinical trial