Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children (CAPSAPED)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Neuropathic Pain
• Intervention / Treatment: Drug: Capsaicin 8% patch; Device: Hydrocolloid dressing

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Philippe J LE MOINE, MD; Phone Number: +33298223956; Email: philippe.lemoine@chu-brest.fr

Study Locations

• France
  • Amiens, France
    • Recruiting
    • CHU d'AMIENS
    • Contact: Catherine DEVOLDERE
  • Angers, France
    • Recruiting
    • CHU d'Angers
    • Contact: Petronela RACHIERU
  • Bordeaux, France
    • Recruiting
    • CHU de Bordeaux
    • Contact: Sylvie BERCIAUD
  • Brest, France
    • Recruiting
    • CHU de Brest
    • Contact: Philippe LE MOINE
  • Brest, France
    • Recruiting
    • CHU de Nantes
    • Contact: Marine LETELLIER
  • Lyon, France
    • Recruiting
    • CHU de Lyon
    • Contact: Sabine SIMONIN
  • Marseille, France
    • Recruiting
    • CHU de Marseille
    • Contact: Sylvain REDON
  • Montpellier, France
    • Recruiting
    • CHU de Montpellier
    • Contact: Frédéric BERNARD
  • Tours, France
    • Recruiting
    • Chu De Tours
    • Contact: Florence UETTWILLER
  • Villejuif, France
    • Recruiting
    • Institut Gustave Roussy
    • Contact: Marie-Anne SEVEQUE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 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.; Other Names: QUTENZA®
Placebo Comparator: 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.	Device: 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 Names: COMFEEL PLUS TRANSPARENT

What is the study measuring?

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
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
Vital signs	Arterial pressure in mmHg	At baseline, Month 1, Month 2, Month 3 and Month 4

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Philippe J LE MOINE, MD, CHU of Brest

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2024
• Primary Completion (Estimated): April 5, 2026
• Study Completion (Estimated): April 5, 2026

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Randomized clinical trial; Pediatric; Neuropathic Pain; Capsaicin
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Neuralgia; Organic Chemicals; Heterocyclic Compounds; Fatty Acids; Lipids; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Hydrocarbons, Cyclic; Alkaloids; Hydrocarbons, Aromatic; Equipment and Supplies; Amides; Catechols; Phenols; Benzene Derivatives; Fatty Acids, Unsaturated; Solanaceous Alkaloids; Polyunsaturated Alkamides; Fatty Acids, Monounsaturated; Bandages; Capsaicin; Transdermal Patch; Bandages, Hydrocolloid
• Other Study ID Numbers: 29BRC21.0184

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No