Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children
NCT ID: NCT05997979
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
46 participants
INTERVENTIONAL
2024-03-05
2026-04-05
Brief Summary
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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 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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* experimental arm : Capsaicin 8% cutaneous patch
* control arm : Hydrocolloid dressing
TREATMENT
SINGLE
The patient should not be aware of the specific aspect of capsaicin 8% patch and the protocol of application will be exactly the same. This should keep the patient blinded for the study treatment.
The nurse who applies the patch is unblinded.
Study Groups
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QUTENZA
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.
Capsaicin 8% patch
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.
Placebo
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.
Hydrocolloid dressing
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.
Interventions
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Capsaicin 8% patch
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.
Hydrocolloid dressing
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Years
17 Years
ALL
No
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Principal Investigators
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Philippe J LE MOINE, MD
Role: PRINCIPAL_INVESTIGATOR
CHU of Brest
Locations
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CHU d'Amiens
Amiens, , France
CHU d'Angers
Angers, , France
CHU de Bordeaux
Bordeaux, , France
CHU de Brest
Brest, , France
CHU de Nantes
Brest, , France
CHU de Lyon
Lyon, , France
CHU de Marseille
Marseille, , France
CHU de Montpellier
Montpellier, , France
CHU de Tours
Tours, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Central Contacts
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Facility Contacts
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Catherine DEVOLDERE
Role: primary
Petronela RACHIERU
Role: primary
Sylvie BERCIAUD
Role: primary
Philippe LE MOINE
Role: primary
Marine LETELLIER
Role: primary
Sabine SIMONIN
Role: primary
Sylvain REDON
Role: primary
Frédéric BERNARD
Role: primary
Florence UETTWILLER
Role: primary
Marie-Anne SEVEQUE
Role: primary
Other Identifiers
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29BRC21.0184
Identifier Type: -
Identifier Source: org_study_id