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First Clinical Study of Erbium-YAG Laser Vaporisation of Cutaneous Neurofibromas

Phase 2/Phase 3
Open (Enrolling)
Cutaneous Neurofibromas

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Trial Information

First Clinical Study of Erbium-YAG Laser Vaporisation of Cutaneous Neurofibromas

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.

Inclusion Criteria:

- Patients with multiple cutaneous neurofibromas with the request for tumor removal

Exclusion Criteria:

- Pregnancy

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The aim of this study is to enhance the quality of life (measured by the Nottingham Health Profile the Rosenberg's Self-Esteem Scale and the SF-36 health survey) of patients suffering from disfigurement due to thousands of cutaneous neurofibromas.

Outcome Description:

The standardized questionnaires are done before and 6 month after the operation in which the tight tumor cluster are phased down and thereby an almost normal skin appearance is achieved.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Wolfgang Happak, Prof. MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Division of Plastic and Reconstructive Surgery, Surgical Clinic, Medical University of Vienna, Austria


Austria: Ethikkommission

Study ID:

EK Nr: 128/2006



Start Date:

April 2006

Completion Date:

November 2012

Related Keywords:

  • Cutaneous Neurofibromas
  • Neurofibromatosis Type 1
  • Morbus Recklinghausen
  • cutaneous neurofibromas
  • Erbium-YAG-Laser
  • Vaporisation
  • Thermal Necrosis
  • Neurofibroma