Treatment of Naevus Flammeus Using Intense Pulsed Light a... | NCT00365118

Studies
Treatment of Naevus Flammeus Using Intense Pulsed Light and Pulsed Dye Laser

NCT00365118

Sponsor

Bispebjerg Hospital

Status

Completed

Last Update Posted

Jun 3, 2008Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Port-Wine Stain

Interventions

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

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Aug 15, 2006

First Submission Date that Met QC Criteria

Aug 16, 2006

First Posted Date

Aug 17, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2008

Last Update Posted Date

Jun 3, 2008Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Pulsed dye laser (Candela), Intense pulsed light (Palomar)	Device

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.).

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Merete Hædersdal, MD, PhD, DrMedSci	Bispebjerg Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bispebjerg Hospital		Copenhagen	Copenhagen Nv	2400	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D019339	Port-Wine Stain
D018324	Hemangioma, Capillary

Ancestor Terms

ID	Term
D012868	Skin Abnormalities
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D054025	Lasers, Dye

Ancestor Terms

ID	Term
D007834	Lasers
D055096	Optical Devices
D004864	Equipment and Supplies
D055618	Radiation Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided