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

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: First Clinical Study of Erbium-YAG Laser Vaporisation of Cutaneous Neurofibromas

Brief 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 Summary:

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.


Sponsor: Medical University of Vienna

Current Primary Outcome: 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. [ Time Frame: 6 months ]

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.


Original Primary Outcome: The aim of this study is to enhance the quality of life of patients suffering from disfigurement due to thousands of cutaneous neurofibromas by phasing down the tight tumor cluster and thereby achieving an almost normal skin appearance. [ Time Frame: 6 months ]

Current Secondary Outcome: With this new method we want to decrease the painfulness, accelerated the time till wound healing as well as reduce the stay in hospital and the incidence of side effects. [ Time Frame: 6 months ]

Original Secondary Outcome: Same as current

Information By: Medical University of Vienna

Dates:
Date Received: June 15, 2009
Date Started: April 2006
Date Completion: November 2012
Last Updated: July 11, 2011
Last Verified: June 2009