Back to resultsTreatment of Leg Telangiectasias With Nd:YAG 1064nm
Primary Purpose
Telangiectasias
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Laser Nd:YAG 1064nm
Sclerotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Telangiectasias focused on measuring telangiectasias, leg, sclerotherapy, laser, glycose
Eligibility Criteria
Inclusion Criteria:
- Patients with leg telangiectasias
Exclusion Criteria:
- Arterial disease
- Varices
- Diabetes
Sites / Locations
- Hospital das Clinicas da FMUSP
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Laser Nd:YAG 1064nm
Sclerotherapy
Arm Description
Patients with leg telangiectasias are treated with 3 sessions of Nd:YAG 1064nm, with 14 days interval
Patients with leg telangiectasias are treated with 3 sessions of sclerotherapy, with 14 days interval
Outcomes
Primary Outcome Measures
treatment of leg telangiectasias
Patients respond after treatment a questionnaire about satisfaction for both the laser and for conventional sclerotherapy.
Treatment of telangiectasias
Patients respond after treatment a questionnaire about satisfaction for both the laser and for conventional sclerotherapy.
Secondary Outcome Measures
Presence of adverse effects
Patients are monitored to adverse effects such as blemishes, scars and ulcers
Pain Scores on the Visual Analog Scale
Patients evaluate pain on the Visual Analog Scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01118390
Brief Title
Treatment of Leg Telangiectasias With Nd:YAG 1064nm
Official Title
Treatment of Leg Telangiectasias With Nd:YAG 1064nm
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
July 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Grupo de Cirurgia Vascular
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Studying the results of treatment of dilated vessels of the lower limbs with laser, and compare them to those obtained with sclerotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telangiectasias
Keywords
telangiectasias, leg, sclerotherapy, laser, glycose
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laser Nd:YAG 1064nm
Arm Type
Experimental
Arm Description
Patients with leg telangiectasias are treated with 3 sessions of Nd:YAG 1064nm, with 14 days interval
Arm Title
Sclerotherapy
Arm Type
Active Comparator
Arm Description
Patients with leg telangiectasias are treated with 3 sessions of sclerotherapy, with 14 days interval
Intervention Type
Device
Intervention Name(s)
Laser Nd:YAG 1064nm
Other Intervention Name(s)
laser, Xeo, Cool Glide
Intervention Description
Patients with leg telangiectasias are treated with 3 sessions of Nd:YAG 1064nm, with 14 days interval
Intervention Type
Other
Intervention Name(s)
Sclerotherapy
Other Intervention Name(s)
glicose
Intervention Description
Patients with leg telangiectasias are treated with 3 sessions of sclerotherapy, with 14 days interval
Primary Outcome Measure Information:
Title
treatment of leg telangiectasias
Description
Patients respond after treatment a questionnaire about satisfaction for both the laser and for conventional sclerotherapy.
Time Frame
first day
Title
Treatment of telangiectasias
Description
Patients respond after treatment a questionnaire about satisfaction for both the laser and for conventional sclerotherapy.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Presence of adverse effects
Description
Patients are monitored to adverse effects such as blemishes, scars and ulcers
Time Frame
after 1 month
Title
Pain Scores on the Visual Analog Scale
Description
Patients evaluate pain on the Visual Analog Scale
Time Frame
After 1 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with leg telangiectasias
Exclusion Criteria:
Arterial disease
Varices
Diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nelson Wolosker, MD, PhD
Organizational Affiliation
Hospital das Clinicas, University of Sao Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marco Munia, MD
Organizational Affiliation
Hospital das Clinicas, University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clinicas da FMUSP
City
Sao Paulo
ZIP/Postal Code
04534000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
6836297
Citation
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.
Results Reference
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PubMed Identifier
11870796
Citation
Coles 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.
Results Reference
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PubMed Identifier
16882176
Citation
Baumler 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.
Results Reference
background
PubMed Identifier
19271368
Citation
Dudelzak J, Hussain M, Goldberg DJ. Vascular-specific laser wavelength for the treatment of facial telangiectasias. J Drugs Dermatol. 2009 Mar;8(3):227-9.
Results Reference
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Treatment of Leg Telangiectasias With Nd:YAG 1064nm
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