An interventional study of Alexandrite laser in Nevus Flammeus, sponsored by Bispebjerg Hospital. Completed at 1 site in Denmark. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2015-02-24.
Sponsored by Bispebjerg Hospital · Not applicable, Interventional, and Treatment
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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.
45 studies on the registry are indexed under Port-Wine Stain; 7 are open to participants now.
This study's enrollment of 19 is below the median of 29 across 30 interventional studies indexed under Port-Wine Stain.
Browse Port-Wine Stain studies →Bispebjerg Hospital is the lead sponsor of 289 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Alexandrite laser
3 different alexandrite laser settings are used in respectively 3 different treatment areas and compared with a non-treated control area.
Also known as: Candela Gentle Max
Reduction in clinical appearance on a 10-point scale
Time frame: 6-8 weeks
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
Clinical assessment of pigmentation
Time frame: 6-8 weeks
Clinical assessment of scar tissue formation
Time frame: 6-8 weeks
The record gives a start of Sep 2013, a primary completion of Dec 2014 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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