Phase
Condition
Oral Facial Pain
Acute Pain
Chronic Pain
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,
FranceSite Not Available
CHU d'Amiens
Amiens 3037854,
FranceActive - Recruiting
CHU d'Angers
Angers,
FranceSite Not Available
CHU d'Angers
Angers,
FranceSite Not Available
CHU d'Angers
Angers 3037656,
FranceActive - Recruiting
CHU de Bordeaux
Bordeaux,
FranceSite Not Available
CHU de Bordeaux
Bordeaux 3031582,
FranceActive - Recruiting
CHU de Brest
Brest,
FranceActive - Recruiting
CHU de Nantes
Brest,
FranceSite Not Available
CHU de Brest
Brest 3030300,
FranceActive - Recruiting
CHU de Nantes
Brest 3030300,
FranceActive - Recruiting
CHU de Lyon
Lyon,
FranceSite Not Available
CHU de Lyon
Lyon 2996944,
FranceActive - Recruiting
CHU de Marseille
Marseille,
FranceSite Not Available
CHU de Marseille
Marseille 2995469,
FranceActive - Recruiting
CHU de Montpellier
Montpellier,
FranceSite Not Available
CHU de Montpellier
Montpellier 2992166,
FranceActive - Recruiting
CHU de Toulouse
Toulouse,
FranceSite Not Available
CHU de Tours
Tours,
FranceSite Not Available
CHU de Tours
Tours 2972191,
FranceActive - Recruiting
Institut Gustave Roussy
Villejuif,
FranceSite Not Available
Institut Gustave Roussy
Villejuif 2968705,
FranceActive - Recruiting

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