Port-Wine StainNCT00365118
Treatment of Naevus Flammeus Using Intense Pulsed Light and Pulsed Dye Laser
A study testing Pulsed dye laser (Candela), Intense pulsed light (Palomar) in people with Port-Wine Stain, run by Bispebjerg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Port-Wine Stain
- What is being tested?
- Pulsed dye laser (Candela), Intense pulsed light (Palomar)
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- Nov 2005to Dec 2007
- 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 2 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Port-Wine Stain
- Being tested
- Pulsed dye laser (Candela), Intense pulsed light (Palomar)
- Keywords
- Port wine stains, naevus flammeus
- Medical subject headings
- Port-Wine Stain, Hemangioma, Capillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed dye laser (Candela), Intense pulsed light (Palomar)Device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2006 (estimated)
- Study startNov 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Port-Wine StainStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Merete Hædersdal, MD, PhD, DrMedSci, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365118
- Sponsor's protocol ID
- KF-01-278867
- Status last verified
- Jun 2008
- First submitted
- 15 Aug 2006
- Last updated
- 3 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Naevus Flammeus Using Intense Pulsed Light and Pulsed Dye Laser
- ClinicalTrials.gov ID
- NCT00365118
- Acronym / sponsor ID
- KF-01-278867
- Conditions
- Port-Wine Stain
- Keywords
- Port wine stains, naevus flammeus
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 17 Aug 2006 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Pulsed dye laser (Candela), Intense pulsed light (Palomar) | Device | – |
Primary outcome
Not reported in the source record.
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 3 Jun 2008.
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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 Hædersdal, MD, PhD, DrMedSci 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 Pulsed dye laser (Candela), Intense pulsed light (Palomar) in people with Port-Wine Stain, 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 1 inclusion and 8 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 3 Jun 2008. 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.
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 3 Jun 2008.