NCT01118390

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 6, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

May 6, 2010

Status Verified

August 1, 2009

Enrollment Period

7 months

First QC Date

April 29, 2010

Last Update Submit

May 5, 2010

Conditions

Keywords

telangiectasiaslegsclerotherapylaserglycose

Outcome Measures

Primary Outcomes (2)

  • treatment of leg telangiectasias

    Patients respond after treatment a questionnaire about satisfaction for both the laser and for conventional sclerotherapy.

    first day

  • Treatment of telangiectasias

    Patients respond after treatment a questionnaire about satisfaction for both the laser and for conventional sclerotherapy.

    1 month

Secondary Outcomes (2)

  • Presence of adverse effects

    after 1 month

  • Pain Scores on the Visual Analog Scale

    After 1 month

Study Arms (2)

Laser Nd:YAG 1064nm

EXPERIMENTAL

Patients with leg telangiectasias are treated with 3 sessions of Nd:YAG 1064nm, with 14 days interval

Device: Laser Nd:YAG 1064nm

Sclerotherapy

ACTIVE COMPARATOR

Patients with leg telangiectasias are treated with 3 sessions of sclerotherapy, with 14 days interval

Other: Sclerotherapy

Interventions

Patients with leg telangiectasias are treated with 3 sessions of Nd:YAG 1064nm, with 14 days interval

Also known as: laser, Xeo, Cool Glide
Laser Nd:YAG 1064nm

Patients with leg telangiectasias are treated with 3 sessions of sclerotherapy, with 14 days interval

Also known as: glicose
Sclerotherapy

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with leg telangiectasias

You may not qualify if:

  • Arterial disease
  • Varices
  • Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clinicas da FMUSP

São Paulo, São Paulo, 04534000, Brazil

Location

Related Publications (4)

  • 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.

    PMID: 6836297BACKGROUND
  • 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.

    PMID: 11870796BACKGROUND
  • 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.

    PMID: 16882176BACKGROUND
  • 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.

    PMID: 19271368BACKGROUND

MeSH Terms

Conditions

Telangiectasis

Interventions

LasersSclerotherapy

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and SuppliesDrug TherapyTherapeutics

Study Officials

  • Nelson Wolosker, MD, PhD

    Hospital das Clinicas, University of Sao Paulo

    STUDY CHAIR
  • Marco Munia, MD

    Hospital das Clinicas, University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 29, 2010

First Posted

May 6, 2010

Study Start

August 1, 2009

Primary Completion

March 1, 2010

Study Completion

July 1, 2010

Last Updated

May 6, 2010

Record last verified: 2009-08

Locations