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Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch for Chronic Postsurgical or Post-traumatic Neuropathic Pain in Children Aged 12 to 17 Years
Led by University Hospital, Brest · Updated on 2025-12-17
46
Participants Needed
10
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of a Capsaicin 8% cutaneous patch in children aged 12 to 17 years who have local chronic neuropathic pain lasting more than two months after trauma or surgery. The study involves children with persistent neuropathic pain despite oral treatment or those with less severe pain without oral treatment. It is a multicenter randomized controlled superiority trial comparing the capsaicin patch to a hydrocolloid dressing as a control. Participants are randomly assigned to receive either the Capsaicin 8% patch, which contains 179 mg of capsaicin and measures 14 cm by 20 cm, or a hydrocolloid dressing measuring 15 cm by 15 cm. The initial treatment is applied at the start of the study, with a second application three months later if needed. The patches are applied to intact, dry, non-irritated skin for 30 minutes on the feet or 60 minutes on other body areas. Children will be monitored through monthly clinical consultations for four months after the first patch application to assess treatment effectiveness and safety. Tolerance is checked during each application and by follow-up phone calls until cold sensation subsides. Researchers will measure changes in neuropathic pain using the Neuropathic Pain Symptom Inventory and evaluate functional disability, vital signs, skin condition, pain related to treatment, use of pain medication, and adverse events throughout the study.
CONDITIONS
Brief Title
Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 12 to 17 years
- Male or female
- Persistent neuropathic pain lasting more than 3 months after surgery or trauma despite treatment
- Neuropathic pain defined by DN4 score of at least 3/7 or 4/10 in a nerve area linked to surgery or trauma
- Treatment and follow-up must be done in an identified study center
- For girls of childbearing potential, use adequate contraception during the study and have a negative pregnancy test within 7 days before first patch application
You will not qualify if you...
- Intellectual disability preventing completion of pain assessments
- Insufficient French language skills for assessments
- Parents refuse consent or minor opposes participation
- Underlying neurological disease
- Ongoing neurotoxic treatment
- Previous treatment with capsaicin
- Skin lesions on the painful area
- Pain located on the face, above the hairline, or near mucous membranes
- Allergy or hypersensitivity to capsaicin or patch ingredients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants receive either a Capsaicin 8% cutaneous patch or a hydrocolloid dressing applied to the painful area at the start of the study. A second application may occur three months later if persistent pain continues. Tolerance is assessed during each application and by phone calls in the days following.
2 in-person visits for treatment application and tolerance assessments, plus phone calls after each application
Duration - 1 month after last treatment application
Participants attend monthly clinical consultations to assess pain, functional disability, vital signs, dermal condition, and use of analgesic medication until 4 months after the first treatment.
Monthly visits for up to 4 months
Trial Site Locations
Total: 10 locations
1
CHU d'Amiens
Amiens, France
Actively Recruiting
2
CHU d'Angers
Angers, France
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3
CHU de Bordeaux
Bordeaux, France
Actively Recruiting
4
CHU de Brest
Brest, France
Actively Recruiting
5
CHU de Nantes
Brest, France
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6
CHU de Lyon
Lyon, France
Actively Recruiting
7
CHU de Marseille
Marseille, France
Actively Recruiting
8
CHU de Montpellier
Montpellier, France
Actively Recruiting
9
CHU de Tours
Tours, France
Actively Recruiting
10
Institut Gustave Roussy
Villejuif, France
Actively Recruiting
Research Team
P
Philippe J LE MOINE, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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