Capsaicin patch for treating chronic pain in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Philippe J LE MOINE, MD — CHU of Brest
• Study coordinator: Philippe LE MOINE, MD
• Email: philippe.lemoine@chu-brest.fr
• Phone: +33298223956

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.