TelangiectasisNCT02090517
Laser Therapy Versus Electrosurgery For Nasal Telangiectasias
A study testing Pulsed Dye Laser, Long Pulsed Alexandrite Laser and Pulsed Dye Laser Plus Nd:YAG Laser in people with Telangiectasis, run by University of California, Davis at 1 site in United States.
Trial summary
The aim of this study is to compare the efficacy of various treatment options for eliminating nasal telangiectasias. The study will compare the outcome of treating nasal telangiectasias with the following; no treatment (control site), alexandrite laser, pulsed dye laser, combination pulsed dye laser and Nd:YAG 1064nm… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Telangiectasis
- What is being tested?
- Pulsed Dye Laser, Long Pulsed Alexandrite Laser and Pulsed Dye Laser Plus Nd:YAG Laser
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Feb 2016
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years of age
- Able to give informed consent themselves
- Willing to return for follow up visit
- 0.5 - 3 millimeter Vessel size
- 5 Non-contiguous nasal vascular lesions
Who cannot join
- Mentally handicapped
- Unable to understand written and oral English
- Incarceration
- Under 18 years of age
- Unwilling to return for follow up
- Pregnant Women
- Vessels less than 0.5 millimeter caliber
- Less than 5 non-contiguous vessels
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California-Davis, Department of Dermatology
Sacramento, California, 95816
About this study
Official title: Evaluation of Laser Therapy Vs Electrosurgery For Nasal Telangiectasias Using A Novel Vascular Imaging Device
The aim of this study is to compare the efficacy of various treatment options for eliminating nasal telangiectasias. The study will compare the outcome of treating nasal telangiectasias with the following; no treatment (control site), alexandrite laser, pulsed dye laser, combination pulsed dye laser and Nd:YAG 1064nm multiplex laser system and electrosurgery.
- Conditions
- Telangiectasis
- Being tested
- Pulsed Dye Laser, Long Pulsed Alexandrite Laser, Pulsed Dye Laser Plus Nd:YAG Laser, Electrodesiccation
- Keywords
- Nasal telangiectasis
- Medical subject headings
- Telangiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Dye LaserDevice
Also called Pulsed dye laser treatments will be performed with a 595 nanometer wavelength, 20 millisecond pulse duration, at 10 Joules/cm2, with a 10 millimeter spot size.
Pulsed dye laser treatments will be performed with a 595 nanometer wavelength, 20 millisecond pulse duration, at 10 Joules/cm2, with a 10 millimeter spot size.
Long Pulsed Alexandrite LaserDevice
Alexandrite laser will be used with a 755 nanometer wavelength, 40 millisecond pulse duration, at 88Joules/cm2, with a 6 millimeter spot size.
Pulsed Dye Laser Plus Nd:YAG LaserDevice
The Cynergy with MultiPlex will be used with a multiplex mode system with a pulse dye laser at 585 nanometer wavelength, 20 milliseconds pulse duration, at 7 Joules/cm2 with a 7 millimeter spot size, with a short delay, followed by a Nd:YAG 1064 nanometer wavelength, 20 millisecond pulse duration, at 50 Joules/cm2 with a 7 millimeter spot size.
ElectrodesiccationProcedure or surgery
A curette is used to scrape off the cancer down to the dermis. The scraping is then paused while an electrosurgical device like a hyfrecator is used next. Electrodesiccation is performed over the raw surgical ulcer to denature a layer of the dermis and the curette is used again over the surgical ulcer to remove denatured dermis down to living tissue.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Dye Laser | Active comparator | Subjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will be treated with pulsed dye laser. Receives: Device: Pulsed Dye Laser |
| Long Pulsed Alexandrite Laser | Active comparator | Subjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will be treated with long pulsed alexandrite laser. Receives: Device: Long Pulsed Alexandrite Laser |
| Pulsed Dye Laser Plus Nd:YAG Laser | Active comparator | Subjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will be treated with pulsed dye laser plus Nd:YAG laser. Receives: Device: Pulsed Dye Laser Plus Nd:YAG Laser |
| Electrodesiccation | Active comparator | Subjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will be treated with electrodesiccation. Receives: Procedure: Electrodesiccation |
| No Treatment | No intervention | Subjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will receive no treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Area of Nasal Telangiectasias by Laser Therapy Vs Electrosurgery
The study will measure the changes in length and width (area) of nasal telangiectasias before and after treatment with the following: no treatment (control site), alexandrite laser, pulsed dye laser, combination pulsed dye laser and Nd:YAG 1064nm multiplex laser system and electrosurgery.
Measured: 3 months
Secondary outcomes (1)
Evaluation of Cosmetic Improvement
Percent perceived improvement for nasal vessels by the patient via questionnaire.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startJun 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: Study was withdrawn because the university wanted to bill study patients for use of the laser.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelangiectasisStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Eisen, M.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090517
- Sponsor's protocol ID
- 430519
- Other IDs
- 430519
- Status last verified
- Jun 2017
- First submitted
- 4 Dec 2013
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Laser Therapy Vs Electrosurgery For Nasal Telangiectasias Using A Novel Vascular Imaging Device
- ClinicalTrials.gov ID
- NCT02090517
- Acronym / sponsor ID
- 430519
- Conditions
- Telangiectasis
- Keywords
- Nasal telangiectasis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was withdrawn because the university wanted to bill study patients for use of the laser.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 18 Mar 2014 (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 aim of this study is to compare the efficacy of various treatment options for eliminating nasal telangiectasias. The study will compare the outcome of treating nasal telangiectasias with the following; no treatment (control site), alexandrite laser, pulsed dye laser, combination pulsed dye laser and Nd:YAG 1064nm multiplex laser system and electrosurgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Pulsed Dye Laser | Active comparator | Device: Pulsed Dye LaserSubjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will be treated with pulsed dye laser. |
| Long Pulsed Alexandrite Laser | Active comparator | Device: Long Pulsed Alexandrite LaserSubjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will be treated with long pulsed alexandrite laser. |
| Pulsed Dye Laser Plus Nd:YAG Laser | Active comparator | Device: Pulsed Dye Laser Plus Nd:YAG LaserSubjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will be treated with pulsed dye laser plus Nd:YAG laser. |
| Electrodesiccation | Active comparator | Procedure: ElectrodesiccationSubjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will be treated with electrodesiccation. |
| No Treatment | No intervention | –Subjects with multiple nose telangiectasias will be enrolled. One nose telangiectasia (of 5) will receive no treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Over 18 years of age
- Able to give informed consent themselves
- Willing to return for follow up visit
- 0.5 - 3 millimeter Vessel size
- 5 Non-contiguous nasal vascular lesions
Key exclusion criteria (8 listed)
- Mentally handicapped
- Unable to understand written and oral English
- Incarceration
- Under 18 years of age
- Unwilling to return for follow up
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 |
|---|---|---|
| Pulsed Dye LaserAlso: Pulsed dye laser treatments will be performed with a 595 nanometer wavelength, 20 millisecond pulse duration, at 10 Joules/cm2, with a 10 millimeter spot size.Pulsed dye laser treatments will be performed with a 595 nanometer wavelength, 20 millisecond pulse duration, at 10 Joules/cm2, with a 10 millimeter spot size. | Device | Pulsed Dye Laser |
| Long Pulsed Alexandrite LaserAlexandrite laser will be used with a 755 nanometer wavelength, 40 millisecond pulse duration, at 88Joules/cm2, with a 6 millimeter spot size. | Device | Long Pulsed Alexandrite Laser |
| Pulsed Dye Laser Plus Nd:YAG LaserThe Cynergy with MultiPlex will be used with a multiplex mode system with a pulse dye laser at 585 nanometer wavelength, 20 milliseconds pulse duration, at 7 Joules/cm2 with a 7 millimeter spot size, with a short delay, followed by a Nd:YAG 1064 nanometer wavelength, 20 millisecond pulse duration, at 50 Joules/cm2 with a 7 millimeter spot size. | Device | Pulsed Dye Laser Plus Nd:YAG Laser |
| ElectrodesiccationA curette is used to scrape off the cancer down to the dermis. The scraping is then paused while an electrosurgical device like a hyfrecator is used next. Electrodesiccation is performed over the raw surgical ulcer to denature a layer of the dermis and the curette is used again over the surgical ulcer to remove denatured dermis down to living tissue. | Procedure or surgery | Electrodesiccation |
Primary outcome
Reduction of Area of Nasal Telangiectasias by Laser Therapy Vs Electrosurgery
Time frame: 3 months
The study will measure the changes in length and width (area) of nasal telangiectasias before and after treatment with the following: no treatment (control site), alexandrite laser, pulsed dye laser, combination pulsed dye laser and Nd:YAG 1064nm multiplex laser system and electrosurgery.
1 secondary outcome
Evaluation of Cosmetic Improvement
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- University of California-Davis Department of Dermatology Clinical ResearchLink provided by the sponsor.
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Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)
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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.
Daniel Eisen, M.D. principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Dye Laser, Long Pulsed Alexandrite Laser and Pulsed Dye Laser Plus Nd:YAG Laser in people with Telangiectasis, run by University of California, Davis at 1 site in United States.
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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 29 Jun 2017. 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 United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of Area of Nasal Telangiectasias by Laser Therapy Vs Electrosurgery (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2017.