Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children

Study Overview
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Brief Summary
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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).

Detailed Description
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Children aged to 12 to 17-years monitored in pediatric pain outpatient clinics in the designed investigation centers for a local chronic neuropathic pain lasting more than 2 months after trauma or surgery are proposed to participate the trial. Children with persistant neuropathic pain (DN4 (Diagnostic Neuropathic Pain) > or = 3/7 ou DN4 >or = 4/10) despite oral treatment following recommendations for neuropathic pain may be enrolled in the study. For children not very painful (NRS-11 (Numeric Rating Scale) < 7 and FDI (Functional Disability Inventory) < 30) and without any oral treatment for neuropathic pain, the study may be proposed as first line treatment. If both the child and his/her parents accept the trial, he/she will be included in the study. It is a multicentric randomized controlled superiority trial in parallel arms : experimental arm: Capsaicin 8% cutaneous patch controlled arm : Hydrocolloid dressing At M0, take place : baseline evaluation, agreement consent signature, inclusion and randomization, as well as first treatment application either capsaicin cutaneous patch or hydrocolloid dressing. , If needed, the treatment may be done twice with a second application three months later (M3). 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 4 months later (M4).

Official Title
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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

Conditions
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Neuropathic Pain, Chronic Pain

Intervention / Treatment
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* Drug: Capsaicin 8% patch
* Device: Hydrocolloid dressing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicentric randomized controlled superiority trial in parallel arms: experimental arm : Capsaicin 8% cutaneous patch control arm : Hydrocolloid dressing
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: QUTENZA<br>The experimental product is QUTENZA®, a cutaneous patch which contains 179 mg of capsaicin (capsaicin 8%).The patch measures 14 cm x 20 cm. The second application takes place three months after the first application. | Drug: Capsaicin 8% patch<br>* Patients will receive Capsaicin 8% patch at the inclusion of the study and three months later if it is necessary (persistant pain). Qutenza should be applied to intact, non-irritated, dry skin, and during 30 minutes for the feet or 60 minutes for other areas of the body.<br>* Other names: QUTENZA®;|
| Placebo Comparator: Placebo<br>The placebo comparator is a hydrocolloid dressing: COMFEEL PLUS TRANSPARENT, a medical device class IIb commercialized by Coloplast. The patch measures 15 cm x 15 cm. The second application takes place three months after the first application. | Device: Hydrocolloid dressing<br>* Patients will receive Hydrocolloid dressing at the inclusion of the study and three months later if it is necessary (persistant pain). Hydrocolloid dressing should be applied to intact, non-irritated, dry skin, and during 30 minutes for the feet or 60 minutes for other areas of the body.<br>* Other names: COMFEEL PLUS TRANSPARENT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in Neuropathic Pain Symptom Inventory score (NPSI) | The decrease in Neuropathic Pain Symptom Inventory score (NPSI) is evaluated before the first application (M0) of capsaicin or placebo and 4 months later (M4). NPSI (Neuropathic Pain Syndrome Inventory) is a questionnaire without support, score from 0 to 100, higher score is worse outcome. | At baseline (day of the patch application) and 4 months after patch application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event monitoring | Adverse event monitoring are collected during patch application and by phone calls in the following days. | At day 0, day 1, day 2, day 3 after patch application | 
| Vital signs | Cardiac frequency in Bpm | At baseline, Month 1, Month 2, Month 3 and Month 4 | 
| Vital signs | Arterial pressure in mmHg | At baseline, Month 1, Month 2, Month 3 and Month 4 | 
| Dermal assessment | Dermal assessment is evaluated with question concerning the treated area (YES/NO) | At baseline | 
| Dermal assessment | Dermal assessment is evaluated with questions concerning the feel of the treated area (YES/NO) | Month 1, Month 2, Month 3 and Month 4 | 
| Treatment related pain and use of analgesic medication | Intake of analgesic medication (YES/NO) | At baseline, day 1, day 2, Month 1, Month 2, Month 3 and Month 4 | 
| Duration of patch application | Duration of patch application in minutes | During patch application : at baseline and at Month 3 if it is applicable | 
| Neuropathic Pain Symptom Inventory score (NPSI) | Global score and subscores of NPSI (Neuropathic Pain Syndrome Inventory) questionnaire without support, score from 0 to 100, higher score is worse outcome | At baseline, Month 1, Month 2, Month 3 and Month 4 | 
| Functional disability evaluation (FDI) | Global score of FDI (Functional Disability Inventory) questionnaire, score from 0 to 60, higher score is worse outcome | At baseline, Month 1, Month 2, Month 3 and Month 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuropathic Pain, Pediatric, Capsaicin, Randomized clinical trial