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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Tessa Mermod, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01759082
First received: December 2, 2012
Last updated: January 1, 2013
Last verified: December 2012
  Purpose

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.


Condition
Port-wine Stains (PWS)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Angioma's Treatment Evaluation With Laser Doppler Imaging (LDI)

Resource links provided by NLM:


Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • Vascularization's percentage of the PWS with Laser Doppler [ Time Frame: For each treatment, spaced about 2 months ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 20
Study Start Date: September 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   1 Year to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
Criteria

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
  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: NCT01759082

Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
Principal Investigator: Anthony DeBuys Roessingh, Dr MD PhD Paediatrics Surgery
  More Information

No publications provided

Responsible Party: Tessa Mermod, Principal Investigator, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT01759082     History of Changes
Other Study ID Numbers: CHP
Study First Received: December 2, 2012
Last Updated: January 1, 2013
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Port-Wine Stain
Congenital Abnormalities
Skin Abnormalities
Skin Diseases

ClinicalTrials.gov processed this record on November 27, 2014