Cutaneous NeurofibromasPhase 2/3NCT00921037
First Clinical Study of Erbium - Yttrium Aluminium Garnet (YAG) Laser Vaporization of Cutaneous Neurofibromas
A Phase 2/3 study testing Erbium-YAG laser vaporization in people with Cutaneous Neurofibromas, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cutaneous Neurofibromas
- What is being tested?
- Erbium-YAG laser vaporization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2006to Nov 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with multiple cutaneous neurofibromas with the request for tumor removal
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Division of Plastic and Reconstructive Surgery, Surgical Clinic, Medical University of Vienna
Vienna, State of Vienna, 1090
Wolfgang Happak, Prof. MD, 0043-1-40400 ext. 6980, lukikriechbaumer@hotmail.com
Wolfgang Happak, Prof. MD
About this study
Official title: First Clinical Study of Erbium-YAG Laser Vaporisation of Cutaneous Neurofibromas
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.
Read the 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.
- Conditions
- Cutaneous Neurofibromas
- Being tested
- Erbium-YAG laser vaporization
- Keywords
- Neurofibromatosis Type 1, Morbus Recklinghausen, cutaneous neurofibromas, Erbium-YAG-Laser, Vaporisation, Thermal Necrosis
- Medical subject headings
- Neurofibromatosis 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erbium-YAG laser vaporizationProcedure or surgery
spot size 2-5 mm diameter, applying about 1,2 -2 J at a frequency of 6-12 Hz
| Study group | Role | What they receive |
|---|---|---|
| Erbium YAG Laser | Experimental | Patients with Neurofibromatosis Type 1 (Recklinghausen) Receives: Procedure: Erbium-YAG laser vaporization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startApr 2006
- Primary completionJan 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cutaneous NeurofibromasStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Wolfgang Happak, Prof. MD, Principal investigator, Division of Plastic and Reconstructive Surgery, Surgical Clinic, Medical University of Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921037
- Sponsor's protocol ID
- EK Nr: 128/2006
- Status last verified
- Jun 2009
- First submitted
- 15 Jun 2009
- Last updated
- 13 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1097/00000637-199106000-00016.
PubMed 1909107Kardorff 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. doi: 10.1046/j.1365-2133.2001.04214.x. No abstract available.
PubMed 11359412Ostertag 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.
PubMed 11896787Querings 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.
PubMed 11109606Roenigk 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.
PubMed 3100595
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Clinical Study of Erbium-YAG Laser Vaporisation of Cutaneous Neurofibromas
- ClinicalTrials.gov ID
- NCT00921037
- Acronym / sponsor ID
- EK Nr: 128/2006
- Conditions
- Cutaneous Neurofibromas
- Keywords
- Neurofibromatosis Type 1, Morbus Recklinghausen, cutaneous neurofibromas, Erbium-YAG-Laser, Vaporisation, Thermal Necrosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 16 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erbium YAG Laser | Experimental | Procedure: Erbium-YAG laser vaporizationPatients with Neurofibromatosis Type 1 (Recklinghausen) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with multiple cutaneous neurofibromas with the request for tumor removal
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erbium-YAG laser vaporizationspot size 2-5 mm diameter, applying about 1,2 -2 J at a frequency of 6-12 Hz | Procedure or surgery | Erbium YAG Laser |
Primary outcome
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.
Time frame: 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.
1 secondary outcome
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.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2011.
- BackgroundAlgermissen B, Müller U, Katalinic D, Berlien HP. Laserbehandlung von kutanen Neurofibromen. journalmed. 12; 2001.
- Background: PubMed 1909107Becker 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.
- BackgroundKardorff B. Neurofibromatose Typ I (Morbus Recklinghausen): Kombinierte Erbium.Yag-Laser- und Exzisionstherapie von kutanen Neurofibromen. Derm 1998; 4:404-406
- Background: PubMed 11359412Moreno 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.
- Background: PubMed 11896787Ostertag 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.
- Background: PubMed 11109606Querings 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.
- Background: PubMed 3100595Roenigk 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.
Related trials for Cutaneous Neurofibromas
RecruitingPhase 1
PAS-004 in Adults Who Have Neurofibromatosis Type 1 With Plexiform Neurofibromas
NF1 Mutation, Neurofibroma Plexiform
Active, not recruitingObservational study
Natural History Study of Cutaneous Neurofibromas in People With NF1
Neurofibromatosis Type 1, Neurofibromatosis 1
Active, not recruitingPhase 1/2
Doxycycline in Cutaneous Schwannoma (NF2)
Neurofibromatosis Type 2
RecruitingObservational study
Cutaneous and Mucosal Manifestations of Neurofribromatosis Type 2 in Children Under 15
Neurofibromatosis 2, Dermatology/Skin - Other
RecruitingPhase 1
Feasibility and Tolerability of IMLYGIC for the Treatment of Cutaneous Neurofibromas in Adults With NF1
NF1, Neurofibromatosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Happak, Prof. MD principal investigator
Division of Plastic and Reconstructive Surgery, Surgical Clinic, Medical University of Vienna, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Erbium-YAG laser vaporization in people with Cutaneous Neurofibromas, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wolfgang Happak, Prof. MD (0043-1-40400 ext. 6980, lukikriechbaumer@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00921037, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2011.