NCT00921037

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

July 13, 2011

Status Verified

June 1, 2009

Enrollment Period

5.8 years

First QC Date

June 15, 2009

Last Update Submit

July 11, 2011

Conditions

Cutaneous Neurofibromas

Keywords

Neurofibromatosis Type 1Morbus Recklinghausencutaneous neurofibromasErbium-YAG-LaserVaporisationThermal Necrosis

Outcome Measures

Primary Outcomes (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.

    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

Secondary Outcomes (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.

    6 months

Study Arms (1)

Erbium YAG Laser

EXPERIMENTAL

Patients with Neurofibromatosis Type 1 (Recklinghausen)

Procedure: Erbium-YAG laser vaporization

Interventions

Erbium-YAG laser vaporizationPROCEDURE

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

Erbium YAG Laser

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Plastic and Reconstructive Surgery, Surgical Clinic, Medical University of Vienna

Vienna, Vienna, 1090, Austria

RECRUITING

Related Publications (7)

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

    BACKGROUND

  • 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.

    PMID: 1909107BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 11359412BACKGROUND

  • 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.

    PMID: 11896787BACKGROUND

  • 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.

    PMID: 11109606BACKGROUND

  • 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.

    PMID: 3100595BACKGROUND

MeSH Terms

Conditions

Neurofibromatosis 1

Condition Hierarchy (Ancestors)

NeurofibromatosesNeurofibromaNerve Sheath NeoplasmsNeoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasmsNeoplastic Syndromes, HereditaryNeurocutaneous SyndromesNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Wolfgang Happak, Prof. MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wolfgang Happak, Prof. MD

CONTACT

0043-1-40400lukikriechbaumer@hotmail.com

Lukas Kriechbaumer, MD

CONTACT

0043-650-8423766lukasKriechbaumer@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2009

First Posted

June 16, 2009

Study Start

April 1, 2006

Primary Completion

January 1, 2012

Study Completion

November 1, 2012

Last Updated

July 13, 2011

Record last verified: 2009-06

Locations

AU(1)