The Angioma's Treatment Evaluation With Laser Doppler Imaging (LDI) (TALDI)

January 1, 2013 updated by: Tessa Mermod, University of Lausanne Hospitals

Based on the Doppler effect, Laser Doppler Imaging (LDI) uses the interaction of light with moving erythrocytes to visualize perfusion in the microcirculatory system.

The new device to be used in this study have been adapted specifically for the application, facilitating its use in clinic. It has been designed to take a standard white light image of the area under inspection simultaneously with the perfusion image to facilitate clinical assessment.

Port-wine stain (PWS) birthmarks are congenital, low-flow vascular malformations of the skin found in approximately 0.3% of children. They are commonly found on the face and neck and may cause serious psychological consequences.

Lasers are the modality of choice for the treatment of PWS birthmarks. The use of PDL is very effective in PWS in closing the blood vessels and diminishing therefore the redness of the skin. Repeated laser treatment is necessary to achieve the desired clinical outcome.

Actually, the efficacy of the treatment of PWS by the laser is obtained by clinical inspection and digital photography.

By measuring the activity and intensity of the microcirculation present in and under the skin, the Laser-Doppler (LDI) will be capable of measuring the effect of Pulsed dye laser (PDL) treatment for port-wine stains.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

20

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

  • Subjects presenting at the CHUV with PWS will be screened and their parents asked to join the study by a member of the research team.
  • Subjects who meet the inclusion criteria will be approached for informed written consent and enrolled in the study.

Description

Inclusion Criteria:

  • children aged 12 months to 6 years old
  • port-wine stains (PWS)
  • phototype's skin I, II or III

Exclusion Criteria:

  • phototype's skin IV, V or VI
  • prior treatment with laser
  • contraindication of general anesthesia
  • refusal from the parents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vascularization's percentage of the PWS with Laser Doppler
Time Frame: For each treatment, spaced about 2 months

After the general anesthesia, we will take a measure before the treatment with the Laser Doppler of the vascularization's percentage of the PWS relative as the safe contralateral side.

An other measure will be made after the treatment.
For each treatment, spaced about 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne Hospitals

Investigators

  • Principal Investigator: Anthony DeBuys Roessingh, Dr MD PhD, Paediatrics Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

October 1, 2013

Study Registration Dates

First Submitted

December 2, 2012

First Submitted That Met QC Criteria

January 1, 2013

First Posted (Estimate)

January 2, 2013

Study Record Updates

Last Update Posted (Estimate)

January 2, 2013

Last Update Submitted That Met QC Criteria

January 1, 2013

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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