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

NCT ID: NCT00921037

Last Updated: 2011-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cutaneous Neurofibromas

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Erbium YAG Laser

Patients with Neurofibromatosis Type 1 (Recklinghausen)

Group Type EXPERIMENTAL

Erbium-YAG laser vaporization

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Erbium-YAG laser vaporization

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Pregnancy
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

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

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wolfgang Happak, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Vienna, Vienna, Austria

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Austria

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Wolfgang Happak, Prof. MD

Role: CONTACT

0043-1-40400 ext. 6980

Lukas Kriechbaumer, MD

Role: CONTACT

0043-650-8423766

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Wolfgang Happak, Prof. MD

Role: primary

0043-1-40400 ext. 6980

References

Explore related publications, articles, or registry entries linked to this study.

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 1909107 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 11359412 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11896787 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11109606 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3100595 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EK Nr: 128/2006

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.