Port-wine Stains (PWS) Clinical Trial
— TALDIOfficial title:
The Angioma's Treatment Evaluation With Laser Doppler Imaging (LDI)
| Verified date | December 2012 |
| Source | University of Lausanne Hospitals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Ethikkommission |
| Study type | Observational |
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.
| Status | Enrolling by invitation |
| Enrollment | 20 |
| Est. completion date | October 2013 |
| Est. primary completion date | September 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 1 Year to 6 Years |
| Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University of Lausanne Hospitals |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Vascularization's percentage of the PWS with Laser Doppler | 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 | No |