TelangiectasiasNCT01118390
Treatment of Leg Telangiectasias With Nd:YAG 1064nm
A study testing Laser Nd:YAG 1064nm and Sclerotherapy in people with Telangiectasias, run by Grupo de Cirurgia Vascular at 1 site in Brazil.
Trial summary
Studying the results of treatment of dilated vessels of the lower limbs with laser, and compare them to those obtained with sclerotherapy. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Telangiectasias
- What is being tested?
- Laser Nd:YAG 1064nm and Sclerotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2009to Jul 2010
- 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 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with leg telangiectasias
Who cannot join
- Arterial disease
- Varices
- Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Studying the results of treatment of dilated vessels of the lower limbs with laser, and compare them to those obtained with sclerotherapy.
- Conditions
- Telangiectasias
- Being tested
- Laser Nd:YAG 1064nm, Sclerotherapy
- Keywords
- telangiectasias, leg, sclerotherapy, laser, glycose
- Medical subject headings
- Telangiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Nd:YAG 1064nmDevice
Also called laser, Xeo, Cool Glide
Patients with leg telangiectasias are treated with 3 sessions of Nd:YAG 1064nm, with 14 days interval
SclerotherapyOther
Also called glicose
Patients with leg telangiectasias are treated with 3 sessions of sclerotherapy, with 14 days interval
| Study group | Role | What they receive |
|---|---|---|
| Laser Nd:YAG 1064nm | Experimental | Patients with leg telangiectasias are treated with 3 sessions of Nd:YAG 1064nm, with 14 days interval Receives: Device: Laser Nd:YAG 1064nm |
| Sclerotherapy | Active comparator | Patients with leg telangiectasias are treated with 3 sessions of sclerotherapy, with 14 days interval Receives: Other: Sclerotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment of leg telangiectasias
Patients respond after treatment a questionnaire about satisfaction for both the laser and for conventional sclerotherapy.
Measured: first day
Treatment of telangiectasias
Patients respond after treatment a questionnaire about satisfaction for both the laser and for conventional sclerotherapy.
Measured: 1 month
Secondary outcomes (2)
Presence of adverse effects
Patients are monitored to adverse effects such as blemishes, scars and ulcers
Measured: after 1 month
Pain Scores on the Visual Analog Scale
Patients evaluate pain on the Visual Analog Scale
Measured: After 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2010 (estimated)
- Study startAug 2009
- Primary completionMar 2010
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for TelangiectasiasStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo de Cirurgia Vascular
- Sponsor type
- University, hospital or other
- Investigators
- Nelson Wolosker, MD, PhD, Study chair, Hospital das Clinicas, University of Sao PauloMarco Munia, MD, Principal investigator, Hospital das Clinicas, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118390
- Sponsor's protocol ID
- 0072/09
- Status last verified
- Aug 2009
- First submitted
- 29 Apr 2010
- Last updated
- 6 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Anderson RR, Parrish JA. Selective photothermolysis: precise microsurgery by selective absorption of pulsed radiation. Science. 1983 Apr 29;220(4596):524-7. doi: 10.1126/science.6836297.
PubMed 6836297Coles CM, Werner RS, Zelickson BD. Comparative pilot study evaluating the treatment of leg veins with a long pulse ND:YAG laser and sclerotherapy. Lasers Surg Med. 2002;30(2):154-9. doi: 10.1002/lsm.10028.
PubMed 11870796Baumler W, Ulrich H, Hartl A, Landthaler M, Shafirstein G. Optimal parameters for the treatment of leg veins using Nd:YAG lasers at 1064 nm. Br J Dermatol. 2006 Aug;155(2):364-71. doi: 10.1111/j.1365-2133.2006.07314.x.
PubMed 16882176Dudelzak J, Hussain M, Goldberg DJ. Vascular-specific laser wavelength for the treatment of facial telangiectasias. J Drugs Dermatol. 2009 Mar;8(3):227-9.
PubMed 19271368
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Leg Telangiectasias With Nd:YAG 1064nm
- ClinicalTrials.gov ID
- NCT01118390
- Acronym / sponsor ID
- 0072/09
- Conditions
- Telangiectasias
- Keywords
- telangiectasias, leg, sclerotherapy, laser, glycose
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Grupo de Cirurgia VascularUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jul 2010 (estimated)
- First posted
- 6 May 2010 (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.
Studying the results of treatment of dilated vessels of the lower limbs with laser, and compare them to those obtained with sclerotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Nd:YAG 1064nm | Experimental | Device: Laser Nd:YAG 1064nmPatients with leg telangiectasias are treated with 3 sessions of Nd:YAG 1064nm, with 14 days interval |
| Sclerotherapy | Active comparator | Other: SclerotherapyPatients with leg telangiectasias are treated with 3 sessions of sclerotherapy, with 14 days interval |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with leg telangiectasias
Key exclusion criteria (3 listed)
- Arterial disease
- Varices
- Diabetes
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 |
|---|---|---|
| Laser Nd:YAG 1064nmAlso: laser, Xeo, Cool GlidePatients with leg telangiectasias are treated with 3 sessions of Nd:YAG 1064nm, with 14 days interval | Device | Laser Nd:YAG 1064nm |
| SclerotherapyAlso: glicosePatients with leg telangiectasias are treated with 3 sessions of sclerotherapy, with 14 days interval | Other | Sclerotherapy |
Primary outcome
treatment of leg telangiectasias
Time frame: first day
Patients respond after treatment a questionnaire about satisfaction for both the laser and for conventional sclerotherapy.
Treatment of telangiectasias
Time frame: 1 month
Patients respond after treatment a questionnaire about satisfaction for both the laser and for conventional sclerotherapy.
2 secondary outcomes
Presence of adverse effects
Time frame: after 1 month
Pain Scores on the Visual Analog Scale
Time frame: After 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2010.
- Background: PubMed 6836297Anderson RR, Parrish JA. Selective photothermolysis: precise microsurgery by selective absorption of pulsed radiation. Science. 1983 Apr 29;220(4596):524-7. doi: 10.1126/science.6836297.
- Background: PubMed 11870796Coles CM, Werner RS, Zelickson BD. Comparative pilot study evaluating the treatment of leg veins with a long pulse ND:YAG laser and sclerotherapy. Lasers Surg Med. 2002;30(2):154-9. doi: 10.1002/lsm.10028.
- Background: PubMed 16882176Baumler W, Ulrich H, Hartl A, Landthaler M, Shafirstein G. Optimal parameters for the treatment of leg veins using Nd:YAG lasers at 1064 nm. Br J Dermatol. 2006 Aug;155(2):364-71. doi: 10.1111/j.1365-2133.2006.07314.x.
- Background: PubMed 19271368Dudelzak J, Hussain M, Goldberg DJ. Vascular-specific laser wavelength for the treatment of facial telangiectasias. J Drugs Dermatol. 2009 Mar;8(3):227-9.
Related trials for Telangiectasias
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RecruitingPhase 4
Foam Sclerotherapy With or Without Transdermal Laser for Reticular Veins and Telangiectasias
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RecruitingPhase 1/2
Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)
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RecruitingPhase 3
A Study to Determine the Safety and Efficacy of NT-501 With M-CHFM
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Active, not recruitingPhase 3
A Pivotal Study of N-Acetyl-L-Leucine on Ataxia-Telangiectasia (A-T)
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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.
Nelson Wolosker, MD, PhD study chair
Hospital das Clinicas, University of Sao Paulo
Marco Munia, MD principal investigator
Hospital das Clinicas, University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Nd:YAG 1064nm and Sclerotherapy in people with Telangiectasias, run by Grupo de Cirurgia Vascular at 1 site in Brazil.
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 3 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 6 May 2010. 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 Brazil. 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?
Results are not available in the source record.
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?
treatment of leg telangiectasias (time frame: first day). The study lists 2 primary outcomes in all. 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 NCT01118390, which also lists 4 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 6 May 2010.