Phase
Condition
Chronic Pain
Oral Facial Pain
Pain (Pediatric)
Treatment
Hydrocolloid dressing
Capsaicin 8% patch
Clinical Study ID
Ages 12-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Children aged 12 to 17 years (lower age limit of 12 has been chosen to ensure NPSIfull filling).
Male or female.
Persistent neuropathic pain more than 3 months after surgery or trauma despitetreatment following recommendations.
Neuropathic pain is defined as a DN4 score equal to or greater than 3/7 or 4/10, andlocalized in a nerve territory explained by the surgery or the trauma.
Treatment, survey and follow up must be realized in an identified investigatingcenter 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 testwithin 7 days prior to the first patch application).
Adequate contraception includes sexual abstinence, progestogen-only oralhormonal contraception, where inhibition of ovulation is not the primary modeof action, male or female condom with or without spermicide, cap, diaphragm orsponge with spermicide, combination of male condom with either cap, diaphragmor sponge with spermicide (double barrier methods)
Exclusion
Exclusion Criteria:
Intellectual deficiency not allowing full filling of NPSI.
Insufficient command of the French language to full fill NPSI and other evaluationtools.
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/orin proximity to mucous membranes
Hypersensitivity to the active substance or to any of the excipients listed insection 6.1 of Qutenza SmPC.
Study Design
Study Description
Connect with a study center
CHU d'Amiens
Amiens,
FranceActive - Recruiting
CHU d'Angers
Angers,
FranceActive - Recruiting
CHU d'Angers
Angers,
FranceSite Not Available
CHU de Bordeaux
Bordeaux,
FranceActive - Recruiting
CHU de Brest
Brest,
FranceActive - Recruiting
CHU de Nantes
Brest,
FranceActive - Recruiting
CHU de Lyon
Lyon,
FranceActive - Recruiting
CHU de Marseille
Marseille,
FranceActive - Recruiting
CHU de Montpellier
Montpellier,
FranceActive - Recruiting
CHU de Toulouse
Toulouse,
FranceSite Not Available
CHU de Tours
Tours,
FranceActive - Recruiting
Institut Gustave Roussy
Villejuif,
FranceActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.