NCT00365118

Brief Summary

The purpose of the trial is to compare efficacy and adverse effects of pulsed dye laser and intense pulsed light in patients with port wine stains.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

June 3, 2008

Status Verified

June 1, 2008

Enrollment Period

2.1 years

First QC Date

August 15, 2006

Last Update Submit

June 2, 2008

Conditions

Port-Wine Stain

Keywords

Port wine stainsnaevus flammeus

Interventions

Pulsed dye laser (Candela), Intense pulsed light (Palomar)DEVICE

Eligibility Criteria

Age2 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with previously untreated and previously laser-treated naevus flammeus. Naevus flammeus measuring at least 5 x 7 cm within a single anatomical area. For example, the face corresponding to dermatomes V1, V2 and V3, back, abdomen, arms and legs.Patients aged two or above.Patients with skin types I-III.

You may not qualify if:

  • Patients below two years of age.
  • Pregnant or breastfeeding patients.
  • Patients with known increased sensitivity to visible light.
  • Patients with a tendency to produce hypertrophic scars or celoids.
  • Patients with skin types IV, V and VI.
  • Patients who are clearly pigmented following recent exposure to the sun or a solarium.
  • Patients treated with Roaccutane during the last six months.
  • Patients who are not considered able to follow the treatment protocol (e.g. severely alcoholic patients, dementia patients, mentally ill patients, etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, Copenhagen Nv, 2400, Denmark

Location

MeSH Terms

Conditions

Port-Wine StainHemangioma, Capillary

Interventions

Lasers, Dye

Condition Hierarchy (Ancestors)

Skin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin and Connective Tissue DiseasesHemangiomaNeoplasms, Vascular TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Merete Hædersdal, MD, PhD, DrMedSci

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 15, 2006

First Posted

August 17, 2006

Study Start

November 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

June 3, 2008

Record last verified: 2008-06

Locations

DK(1)