Cutaneous Neurofibromas Clinical Trial
Official title:
First Clinical Study of Erbium-YAG Laser Vaporisation of Cutaneous Neurofibromas
The purpose of this study is to determine whether multiple cutaneous neurofibromas in patients with neurofibromatosis type 1 can be removed with an erbium-YAG-laser.
With a prevalence of 1 in 3-5000 births, neurofibromatosis Type I is one of the most common
genetic defects. The mode of inheritance is autosomal dominant and affects a gene (NF1),
which is responsible for the production of the tumor suppressor protein neurofibromin. The
consequence is an uninhibited expansion of neural tissue which leads amongst others to
cosmetic disfigurement of the patients. In comparison to the plexiform neurofibromas the
cutaneous tumors do not undergo malignant transformation.
Excision and CO2 laser vaporisation were established as standard treatment but cause
unattractive scars.
In one operation more than 500 neurofibromas can be removed with an Erbium: YAG laser (2940
nm). The tumors are dissected by shooting holes into the skin and vaporising the
neurofibromas in-between or underneath. Specimen are harvested after Er: YAG-, CO2 - and
electrosurgical treatment to evaluate the difference of thermal necrosis histologically and
photographs are taken to assess the cosmetic results.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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||
| Completed |
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Phase 1 | |
| Completed |
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Phase 0 |