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

Sponsor

Medical University of Vienna (Other)

Overall Status

Unknown status

CT.gov ID

NCT00921037

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cutaneous Neurofibromas	Procedure: Erbium-YAG laser vaporization	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2006

Anticipated Primary Completion Date :

Jan 1, 2012

Anticipated Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Erbium YAG Laser Patients with Neurofibromatosis Type 1 (Recklinghausen)	Procedure: Erbium-YAG laser vaporization spot size 2-5 mm diameter, applying about 1,2 -2 J at a frequency of 6-12 Hz

Arm

Intervention/Treatment

Experimental: Erbium YAG Laser

Patients with Neurofibromatosis Type 1 (Recklinghausen)

Procedure: Erbium-YAG laser vaporization

spot size 2-5 mm diameter, applying about 1,2 -2 J at a frequency of 6-12 Hz

Outcome Measures

Primary Outcome Measures

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. [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.

Secondary Outcome Measures

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. [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with multiple cutaneous neurofibromas with the request for tumor removal

Exclusion Criteria:

Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Plastic and Reconstructive Surgery, Surgical Clinic, Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator: Wolfgang Happak, Prof. MD, Division of Plastic and Reconstructive Surgery, Surgical Clinic, Medical University of Vienna, Austria