CClinicalTrials.gg
Status unknownNCT01759082TALDIUpdated Jan 2, 2013

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

An observational study in Port-wine Stains (PWS), sponsored by University of Lausanne Hospitals. Status unknown. Open to participants aged 1 Year to 6 Years. Per ClinicalTrials.gov, last updated 2013-01-02.

Sponsored by University of Lausanne Hospitals · Observational

The sponsor has not verified this record recently (last verified Dec 2012), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Ages
1 Year to 6 Years
Sex
All
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Study 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.

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Conditions studied

  • Port-wine Stains (PWS)
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In context

Hemangioma, Capillary

83 studies on the registry are indexed under Hemangioma, Capillary; 8 are open to participants now.

This study's planned enrollment of 20 is below the median of 143 across 18 observational studies indexed under Hemangioma, Capillary.

Browse Hemangioma, Capillary studies →

Lead sponsor

University of Lausanne Hospitals is the lead sponsor of 118 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 6 Years
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No
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What researchers measure

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.

    Time frame: For each treatment, spaced about 2 months

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01759082
Lead sponsor
University of Lausanne Hospitals
Responsible party
Tessa Mermod (Principal Investigator, University of Lausanne Hospitals) — Principal investigator
First posted
Jan 2, 2013
Start date
Sep 2012
Primary completion
Sep 2013 (estimated)
Completion
Oct 2013 (estimated)
Last update
Jan 2, 2013

Study contacts

Anthony DeBuys Roessingh, Dr MD PhD
principal investigator · Paediatrics Surgery

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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