An interventional study of ADVATx laser treatment in Port-wine Stains (PWS) and Vascular Birthmark, sponsored by Szeged University. Recruiting at 1 site in Hungary. Open to participants aged 7 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by Szeged University · Not applicable, Interventional, and Treatment
The primary objective of the present study is to get experiences with the use of CE-marked ADVATx laser treatment for port-wine stains.
Secondary objectives: To investigate the clinical efficacy of ADVATx laser treatment for port-wine stains.
To investigate the potential side effects (erythema, hyperpigmentation, oedema, pain, swelling, skin burning, blisters) of the treatment.
Patients in the study will receive ADVATx laser treatment (1 treatment per month for 4 months) The treatment takes approximately 10-30 minutes per session. The treatment lasts for a total of 5 months for one patient. At each treatment session photographic documentation will be performed. PRO will be assessed by a questionnaire. At the end of the study, the patient rates the treatment and improvement on a Patient Satisfaction Scale.
Prospective testing and evaluation of a ADVATx, a CE marked device within its intended use, carried out in one centre.
The ADVATx™ laser system, a solid-state laser with wavelengths of 589 nm and 1319 nm. It offers a solution for an exceptionally wide range of indications. It can treat more than 15 indications related to vascular lesions and other dermatological problems with excellent results and high patient safety. It is extremely economical to operate.
Only medical personnel qualified to use medical lasers are authorised to use them.
EUDAMED registration
Advalight card with SRN number:
https://ec.europa.eu/tools/eudamed/#/screen/search-eo/8de1b38d-a0dc-4315-b068-3416928deabe Actor ID/SRN: DK-MF-000010334 Classification of ADVATx: Class IIb medical device
79 studies on the registry are indexed under Port-Wine Stain; 7 are open to participants now.
This study's planned enrollment of 20 is below the median of 30 across 53 interventional studies indexed under Port-Wine Stain.
Browse Port-Wine Stain studies →Szeged University is the lead sponsor of 53 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
4. epilepsy, 5. fever, infectious diseases, 6. the patient is within one month or currently enrolled in another clinical trial.
AdvaTx laser treated patients
Device: ADVATx laser treatment
Patients in the study will receive ADVATx laser treatment (1 treatment per month for 4 months) The treatment takes approximately 10-30 minutes per session. The treatment lasts for a total of 5 months for one patient. At each treatment session photographic documentation will be performed. PRO will be assessed by a questionnaire. At the end of the study, the patient rates the treatment and improvement on a Patient Satisfaction Scale.
Change in lesion presentation measured by Investigator Global Assessment (IGA)
The IGA is a five-point scale from 0 (no change) to 4 (complete or nearly complete clearance). Three blinded dermatologists will review standardized clinical photographs to evaluate each treated area. Results will be reported as the average IGA score for each treatment method.
Time frame: 5 months
Patient satisfaction score
Patients will rate their satisfaction with the treated area using a 0-6 scale, where 0 indicates no satisfaction and 6 indicates very satisfied.
Time frame: 5 months
Pain score during laser treatment measured by Visual Analog Score (VAS)
Participants will assess their pain during each treatment using a Visual Analog Scale (VAS), which ranges from 0 (no pain) to 10 (the worst imaginable pain).
Time frame: 5 months
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Szeged University