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
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
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014