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

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ClinicalTrials.gov Identifier: NCT00921037
Recruitment Status : Unknown
Verified June 2009 by Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : June 16, 2009
Last Update Posted : July 13, 2011
Sponsor:
Information provided by:

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  (Clinical Trial)
Estimated Enrollment : 12 participants
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 : April 2006
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : November 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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00921037


Contacts
Contact: Wolfgang Happak, Prof. MD 0043-1-40400 ext 6980 lukikriechbaumer@hotmail.com
Contact: Lukas Kriechbaumer, MD 0043-650-8423766 lukasKriechbaumer@meduniwien.ac.at

Locations
Austria
Division of Plastic and Reconstructive Surgery, Surgical Clinic, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Wolfgang Happak, Prof. MD    0043-1-40400 ext 6980    lukikriechbaumer@hotmail.com   
Principal Investigator: Wolfgang Happak, Prof. MD         
Sub-Investigator: Lukas Kriechbaumer, MD         
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
More Information

Publications:
Responsible Party: Wolfgang Happak, Prof. MD, Division of Plastic and Reconstructive Surgery, Surgical Clinic, Medical University of Vienna, Austria
ClinicalTrials.gov Identifier: NCT00921037     History of Changes
Other Study ID Numbers: EK Nr: 128/2006
First Posted: June 16, 2009    Key Record Dates
Last Update Posted: July 13, 2011
Last Verified: June 2009

Keywords provided by Medical University of Vienna:
Neurofibromatosis Type 1
Morbus Recklinghausen
cutaneous neurofibromas
Erbium-YAG-Laser
Vaporisation
Thermal Necrosis

Additional relevant MeSH terms:
Neurofibroma
Neurofibromatoses
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn