Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children

NCT05997979 | Recruiting Phase 3

• 1 other identifier: 29BRC21.0184
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 10

Brief Summary

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).

Conditions

Neuropathic Pain; Chronic Pain

Keywords

Neuropathic Pain; Pediatric; Capsaicin; Randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Adverse event monitoring

  At day 0, day 1, day 2, day 3 after patch application

• Vital signs

  At baseline, Month 1, Month 2, Month 3 and Month 4

• Vital signs

  At baseline, Month 1, Month 2, Month 3 and Month 4

• Dermal assessment

  At baseline

• Dermal assessment

  Month 1, Month 2, Month 3 and Month 4

Study Arms (2)

QUTENZA

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Capsaicin 8% patch DRUG

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.

Also known as: QUTENZA®

QUTENZA

Hydrocolloid dressing DEVICE

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.

Also known as: COMFEEL PLUS TRANSPARENT

Placebo

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (10)

CHU d'Amiens

Amiens, France

RECRUITING

CHU d'Angers

Angers, France

RECRUITING

CHU de Bordeaux

Bordeaux, France

RECRUITING

CHU de Brest

Brest, France

RECRUITING

CHU de Nantes

Brest, France

RECRUITING

CHU de Lyon

Lyon, France

RECRUITING

CHU de Marseille

Marseille, France

RECRUITING

CHU de Montpellier

Montpellier, France

RECRUITING

CHU de Tours

Tours, France

RECRUITING

Institut Gustave Roussy

Villejuif, France

RECRUITING

MeSH Terms

Conditions

Neuralgia; Chronic Pain

Interventions

Capsaicin; Transdermal Patch; Bandages, Hydrocolloid

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Equipment and Supplies; Bandages

Study Officials

• Philippe J LE MOINE, MD

  CHU of Brest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe J LE MOINE, MD

CONTACT

+33298223956; philippe.lemoine@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: There is no mock cutaneous patch available for capsaicin 8% cutaneous patch. So we have chosen hydrocolloid dressing for placebo since it has no known effect on neuropathic pain and the tolerability is expected as excellent. 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentric randomized controlled superiority trial in parallel arms: * experimental arm : Capsaicin 8% cutaneous patch * control arm : Hydrocolloid dressing

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 18, 2023
• Study Start: March 5, 2024
• Primary Completion: April 5, 2026
• Study Completion: April 5, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• 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.

Locations

FR (10)