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Clinical Trials/NCT01759082
NCT01759082
Unknown
Not Applicable

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

University of Lausanne Hospitals0 sites20 target enrollmentSeptember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Port-wine Stains (PWS)
Sponsor
University of Lausanne Hospitals
Enrollment
20
Primary Endpoint
Vascularization's percentage of the PWS with Laser Doppler
Last Updated
13 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
October 2013
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Lausanne Hospitals
Responsible Party
Principal Investigator
Principal Investigator

Tessa Mermod

Principal Investigator

University of Lausanne Hospitals

Eligibility 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

Outcomes

Primary Outcomes

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.

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