Actively Recruiting
Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children
Led by University Hospital, Brest · Updated on 2025-12-17
46
Participants Needed
10
Research Sites
108 weeks
Total Duration
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AI-Summary
What this Trial Is About
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
Official 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 recommended treatment
- Neuropathic pain defined by a DN4 score of 3/7 or higher, or 4/10 or higher, localized to nerve territory related to surgery or trauma
- Treatment, monitoring, and follow-up conducted at a designated study center
- For girls of childbearing potential: use of adequate contraception during the study and a negative pregnancy test within 7 days before first patch application
You will not qualify if you...
- Intellectual disability preventing completion of the Neuropathic Pain Symptom Inventory (NPSI)
- Insufficient French language skills to complete NPSI and evaluations
- Parents refuse consent
- Minor patient opposes participation
- Underlying neurological disease
- Current neurotoxic treatment
- Previous treatment with capsaicin
- Skin lesions on the pain area
- Pain area on the face above the hairline, scalp, or near mucous membranes
- Hypersensitivity to capsaicin or any excipients in the patch
AI-Screening
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Trial Site Locations
Total: 10 locations
1
CHU d'Amiens
Amiens, France
Actively Recruiting
2
CHU d'Angers
Angers, France
Actively Recruiting
3
CHU de Bordeaux
Bordeaux, France
Actively Recruiting
4
CHU de Brest
Brest, France
Actively Recruiting
5
CHU de Nantes
Brest, France
Actively Recruiting
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
CONTACT
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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