Nevus FlammeusNCT01968681
Treatment of Nevus Flammeus With Alexandrite Laser
A study testing Alexandrite laser in people with Nevus Flammeus, run by Bispebjerg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Nevus Flammeus
- What is being tested?
- Alexandrite laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Nevus Flammeus
- Being tested
- Alexandrite laser
- Medical subject headings
- Port-Wine Stain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alexandrite laserProcedure or surgery
Also called Candela Gentle Max
3 different alexandrite laser settings are used in respectively 3 different treatment areas and compared with a non-treated control area.
| Study group | Role | What they receive |
|---|---|---|
| Alexandrite laser treatment | Experimental | Not described Receives: Procedure: Alexandrite laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in clinical appearance on a 10-point scale
Measured: 6-8 weeks
Secondary outcomes (2)
Skin reflectance measurement to assess degree of redness
Measured: 6-8 weeks
Skin reflectance to assess degree of pigmentation
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nevus FlammeusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merete Haedersdal, Bispebjerg Hospital
- Investigators
- Merete Haedersdal, Professor, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968681
- Sponsor's protocol ID
- H-4-2013-066
- Status last verified
- Feb 2015
- First submitted
- 21 Oct 2013
- Last updated
- 24 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Nevus Flammeus With Alexandrite Laser
- ClinicalTrials.gov ID
- NCT01968681
- Acronym / sponsor ID
- H-4-2013-066
- Conditions
- Nevus Flammeus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alexandrite laser treatment | Experimental | Procedure: Alexandrite laser |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alexandrite laserAlso: Candela Gentle Max3 different alexandrite laser settings are used in respectively 3 different treatment areas and compared with a non-treated control area. | Procedure or surgery | Alexandrite laser treatment |
Primary outcome
Reduction in clinical appearance on a 10-point scale
Time frame: 6-8 weeks
2 secondary outcomes
Skin reflectance measurement to assess degree of redness
Time frame: 6-8 weeks
Skin reflectance to assess degree of pigmentation
Time frame: 6-8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merete Haedersdal, Professor principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alexandrite laser in people with Nevus Flammeus, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in clinical appearance on a 10-point scale (time frame: 6-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2015; AzTrials last refreshed its copy on 8 Nov 2026.