The Angioma's Treatment Evaluation With Laser Doppler Imaging (LDI)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 20
- Primary Endpoint
- Vascularization's percentage of the PWS with Laser Doppler
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Year to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Tessa Mermod
Principal Investigator
University of Lausanne Hospitals