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

Phase 2

• Conditions: Cutaneous Neurofibromas
• Interventions: Procedure: Erbium-YAG laser vaporization

• Registration Number: NCT00921037
• Lead Sponsor: Medical University of Vienna

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 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 Timeline

• Study Start: 2006-04
• Status Verified: 2009-06
• Study First Submitted: 2009-06-15
• Study First Submitted QC: 2009-06-15
• Study First Posted: 2009-06-16
• Last Update Submitted: 2011-07-11
• Last Update Posted: 2011-07-13
• Primary Completion: 2012-01
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Erbium YAG Laser	Erbium-YAG laser vaporization	Patients with Neurofibromatosis Type 1 (Recklinghausen)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

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