NCT00921037

First Clinical Study of Erbium - Yttrium Aluminium Garnet (YAG) Laser Vaporization of Cutaneous Neurofibromas

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cutaneous Neurofibromas

Interventions

Type	Name	Description
PROCEDURE	Erbium-YAG laser vaporization	spot size 2-5 mm diameter, applying about 1,2 -2 J at a frequency of 6-12 Hz

Timeline

• Start date: 2006-04-01
• Primary completion: 2012-01-01
• Completion: 2012-11-01
• First posted: 2009-06-16
• Last updated: 2011-07-13

Locations

1 site across 1 country: Austria