Treatment of Nevus Flammeus With Alexandrite Laser | NCT01968681

Studies
Treatment of Nevus Flammeus With Alexandrite Laser

NCT01968681

Sponsor

Bispebjerg Hospital

Status

Completed

Last Update Posted

Feb 24, 2015Estimated

Enrollment

19Actual

Phase

Not Applicable

Conditions

Nevus Flammeus

Interventions

Alexandrite laser

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

Feb 2015

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

Sep 2013

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Oct 21, 2013

First Submission Date that Met QC Criteria

Oct 21, 2013

First Posted Date

Oct 24, 2013Estimated

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

Feb 22, 2015

Last Update Posted Date

Feb 24, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Nevus flammeus is a congenital vascular malformation. Nevus flammeus is traditionally treated with pulsed dye lasers (PDL); however, around 20 percent of patients are poor responders and do not get satisfactory results from pulsed dye laser treatments.

Small studies with alexandrite lasers indicate that this may be an alternative treatment for individuals with nevus flammeus. This study assesses the clinical effect and side effects of alexandrite laser treatment for nevus flammeus using different treatment settings.

Detailed Description

Not provided

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

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Alexandrite laser treatment	Experimental		Procedure: Alexandrite laser

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alexandrite laser	Procedure	3 different alexandrite laser settings are used in respectively 3 different treatment areas and compared with a non-treated control area.	Alexandrite laser treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in clinical appearance on a 10-point scale		6-8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Skin reflectance measurement to assess degree of redness		6-8 weeks
Skin reflectance to assess degree of pigmentation		6-8 weeks

Other Outcomes

Measure	Description	Time Frame
Clinical assessment of pigmentation		6-8 weeks
Clinical assessment of scar tissue formation		6-8 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

10 or more years of age
Fitzpatrick Skin Type I-III
Previously untreated or pulsed dye laser-insufficiently treated nevus flammeus
Nevus flammeus size minimum 8 x 2 centimeter within one anatomical region
Written and oral informed consent

Exclusion Criteria:

Known light sensibility toward visible light
Tendency to develop hypertrophic scars or keloids
Fitzpatrick Skin Type IV-VI
Individuals, that are obviously pigmented due to recent sun exposure or sun beds
Treatment with systemic retinoids within 6 months
Pregnancy and lactation
Unwillingness to complete protocol

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 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 Haedersdal, Professor	Bispebjerg Hospital	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D019339	Port-Wine Stain

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
D053844	Lasers, Solid-State

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