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

Cutaneous Neurofibromas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00921037
• Other study ID #: EK Nr: 128/2006
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: June 15, 2009
• Last updated: July 11, 2011
• Start date: April 2006
• Est. completion date: November 2012

Study information

• Verified date: June 2009
• Source: Medical University of Vienna
• Contact: Wolfgang Happak, Prof. MD
• Phone: 0043-1-40400
• Email: lukikriechbaumer[@]hotmail.com
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: November 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cutaneous Neurofibromas
• Nerve Sheath Neoplasms
• Neurofibroma
• Neurofibromatoses

Intervention

Procedure:
• Erbium-YAG laser vaporization
spot size 2-5 mm diameter, applying about 1,2 -2 J at a frequency of 6-12 Hz

Locations

Country	Name	City	State
Austria	Division of Plastic and Reconstructive Surgery, Surgical Clinic, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (7)

Algermissen B, Müller U, Katalinic D, Berlien HP. Laserbehandlung von kutanen Neurofibromen. journalmed. 12; 2001.

Becker DW Jr. Use of the carbon dioxide laser in treating multiple cutaneous neurofibromas. Ann Plast Surg. 1991 Jun;26(6):582-6. — View Citation

Kardorff B. Neurofibromatose Typ I (Morbus Recklinghausen): Kombinierte Erbium.Yag-Laser- und Exzisionstherapie von kutanen Neurofibromen. Derm 1998; 4:404-406

Moreno JC, Mathoret C, Lantieri L, Zeller J, Revuz J, Wolkenstein P. Carbon dioxide laser for removal of multiple cutaneous neurofibromas. Br J Dermatol. 2001 May;144(5):1096-8. — View Citation

Ostertag JU, Theunissen CC, Neumann HA. Hypertrophic scars after therapy with CO2 laser for treatment of multiple cutaneous neurofibromas. Dermatol Surg. 2002 Mar;28(3):296-8. — View Citation

Querings K, Fuchs D, Küng EE, Hafner J. [CO2-laser therapy of stigmatizing cutaneous lesions in tuberous sclerosis (Bourneville-Pringle) and in neurofibromatosis 1 (von Recklinghausen)]. Schweiz Med Wochenschr. 2000 Nov 11;130(45):1738-43. German. — View Citation

Roenigk RK, Ratz JL. CO2 laser treatment of cutaneous neurofibromas. J Dermatol Surg Oncol. 1987 Feb;13(2):187-90. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	6 months	No
Secondary	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	No