Clinical trial NCT00921037: First Clinical Study of Erbium - Yttrium Aluminium Garnet (YAG) Laser Vaporization of Cutaneous Neurofibromas
Official title: First Clinical Study of Erbium-YAG Laser Vaporisation of Cutaneous Neurofibromas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Cutaneous Neurofibromas
Keywords: Neurofibromatosis Type 1
Morbus Recklinghausen
cutaneous neurofibromas
Erbium-YAG-Laser
Vaporisation
Thermal Necrosis
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-06-16
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: 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.
timeFrame: 6 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Division of Plastic and Reconstructive Surgery, Surgical Clinic, Medical University of Vienna
Study officials:
affiliation: Division of Plastic and Reconstructive Surgery, Surgical Clinic, Medical University of Vienna, Austria
name: Wolfgang Happak, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Algermissen B, Müller U, Katalinic D, Berlien HP. Laserbehandlung von kutanen Neurofibromen. journalmed. 12; 2001.
citation: Becker DW Jr. Use of the carbon dioxide laser in treating multiple cutaneous neurofibromas. Ann Plast Surg. 1991 Jun;26(6):582-6. doi: 10.1097/00000637-199106000-00016.
citation: Kardorff B. Neurofibromatose Typ I (Morbus Recklinghausen): Kombinierte Erbium.Yag-Laser- und Exzisionstherapie von kutanen Neurofibromen. Derm 1998; 4:404-406
citation: 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. doi: 10.1046/j.1365-2133.2001.04214.x. No abstract available.
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. doi: 10.1046/j.1524-4725.2002.01145.x.
citation: Querings K, Fuchs D, Kung 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.
citation: Roenigk RK, Ratz JL. CO2 laser treatment of cutaneous neurofibromas. J Dermatol Surg Oncol. 1987 Feb;13(2):187-90. doi: 10.1111/j.1524-4725.1987.tb00517.x.