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

NCT01759082 | Unknown

• 1 other identifier: CHP
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Port-wine Stains (PWS)

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

MeSH Terms

Conditions

Port-Wine Stain

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Anthony DeBuys Roessingh, Dr MD PhD

  Paediatrics Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2012
• First Posted: January 2, 2013
• Study Start: September 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: January 2, 2013

Record last verified: 2012-12