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Treatment of Leg Telangiectasias With Nd:YAG 1064nm

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Grupo de Cirurgia Vascular
ClinicalTrials.gov Identifier:
NCT01118390
First received: April 29, 2010
Last updated: May 5, 2010
Last verified: August 2009
  Purpose

Studying the results of treatment of dilated vessels of the lower limbs with laser, and compare them to those obtained with sclerotherapy.


Condition Intervention
Telangiectasias
Device: Laser Nd:YAG 1064nm
Other: Sclerotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Leg Telangiectasias With Nd:YAG 1064nm

Further study details as provided by Grupo de Cirurgia Vascular:

Primary Outcome Measures:
  • treatment of leg telangiectasias [ Time Frame: first day ] [ Designated as safety issue: No ]
    Patients respond after treatment a questionnaire about satisfaction for both the laser and for conventional sclerotherapy.

  • Treatment of telangiectasias [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Patients respond after treatment a questionnaire about satisfaction for both the laser and for conventional sclerotherapy.


Secondary Outcome Measures:
  • Presence of adverse effects [ Time Frame: after 1 month ] [ Designated as safety issue: Yes ]
    Patients are monitored to adverse effects such as blemishes, scars and ulcers

  • Pain Scores on the Visual Analog Scale [ Time Frame: After 1 month ] [ Designated as safety issue: No ]
    Patients evaluate pain on the Visual Analog Scale


Enrollment: 30
Study Start Date: August 2009
Estimated Study Completion Date: July 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laser Nd:YAG 1064nm
Patients with leg telangiectasias are treated with 3 sessions of Nd:YAG 1064nm, with 14 days interval
Device: Laser Nd:YAG 1064nm
Patients with leg telangiectasias are treated with 3 sessions of Nd:YAG 1064nm, with 14 days interval
Other Names:
  • laser
  • Xeo
  • Cool Glide
Active Comparator: Sclerotherapy
Patients with leg telangiectasias are treated with 3 sessions of sclerotherapy, with 14 days interval
Other: Sclerotherapy
Patients with leg telangiectasias are treated with 3 sessions of sclerotherapy, with 14 days interval
Other Names:
  • glicose
  • sclerotherapy

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with leg telangiectasias

Exclusion Criteria:

  • Arterial disease
  • Varices
  • Diabetes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118390

Locations
Brazil
Hospital das Clinicas da FMUSP
Sao Paulo, Brazil, 04534000
Sponsors and Collaborators
Grupo de Cirurgia Vascular
Investigators
Study Chair: Nelson Wolosker, MD, PhD Hospital das Clinicas, University of Sao Paulo
Principal Investigator: Marco Munia, MD Hospital das Clinicas, University of Sao Paulo
  More Information

Publications:
Responsible Party: Marco Antonio Munia, Departamento de Cirurgia Vascular HCFMUSP
ClinicalTrials.gov Identifier: NCT01118390     History of Changes
Other Study ID Numbers: 0072/09
Study First Received: April 29, 2010
Last Updated: May 5, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Grupo de Cirurgia Vascular:
telangiectasias
leg
sclerotherapy
laser
glycose

Additional relevant MeSH terms:
Telangiectasis
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014