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Mikroperfusions-Pilotstudie zur Korrelation von Schmerzreaktion und neurogener Entzündung bei photodynamischer Therapie superfizieller Basaliome (English: Microperfusion-pilotstudy to correlate pain and neurogenic inflammation induced by photodynamic therapy of superficial basal cell carcinomas)

Mikroperfusions-Pilotstudie zur Korrelation von Schmerzreaktion und neurogener Entzündung bei photodynamischer Therapie superfizieller Basaliome (English: Microperfusion-pilotstudy to correlate pain and neurogenic inflammation induced by photodynamic therapy of superficial basal cell carcinomas)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-006136-29-AT
Enrollment
15
Registered
2006-07-11
Start date
2006-12-12
Completion date
Unknown
Last updated
2016-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Superficial basal cell carcinoma

Interventions

Product Name: Capsaicin 0.05% Creme Pharmaceutical Form: Cream Pharmaceutical form of the placebo: Cream Route of administration of the placebo: Cutaneous use Pharmaceutical Form:

Sponsors

Peter Wolf MD, Department of Dermatology, Medical University of Graz
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion: 1) age > 18 years 2) patients with superficial basal cell carcinomas on trunk or extremities Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion: 1) severe general diseases or metastatic tumors 2) systemic immunosuppressive therapy 3) photosensitive skin diseases such as porphyria, Xeroderma pigmentosum or other diseases with defective repair mechanism DNA-repair 4) Autoimmundermatoses (Lupus erythemathodes, Dermatomyositis) 5) Antinuclear antibodies (ds-DNA, Ro/SSA und La/SSB) 6) Known allergy to drugs used in the study (Metvix®, Capsaicin 0,05%-Creme, Diprosicc) 7) pregnancy or lactation 8) coagulopathy or treatment with anticoagulant therapy (e.g. treatment with Marcoumar® oder Sintrom®) 9) Pigmented or sklerodermiform variant of basal cell carcinomas 10) Location of the basalioma in the face

Design outcomes

Primary

MeasureTime frame
Main Objective: To test whether pretreatment of superficial basal cell carcinomas with capsaicin cream reduces neurogenic inflammation and pain during photodynamic treatment;Secondary Objective: ;Primary end point(s): Pain reaction Neuropeptide CGRP

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026