ADVATx laser treatment for port-wine stains (vascular birthmarks)
Official title: Study of the Effectiveness of the ADVATx Laser in the Treatment of Port-wine Stains
Run by Szeged University · NCT07250945 · Data updated 2026-11-12
This project will test whether four monthly ADVATx laser treatments can lighten port-wine stains in people with lesions at least 15 cm² and Fitzpatrick skin types I–IV.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 7 Years to 65 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Szeged University Academic / other |
| Locations | 1 site (Szeged, Csongrád-Csanád Vármegye) |
| Status | Recruiting |
| Started | December 10, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | February 6, 2026 |
| Trial ID | NCT07250945 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People with port-wine stains of at least 15 cm², Fitzpatrick skin types I–IV, who can provide informed consent (or have parental consent) and meet medical eligibility criteria are appropriate candidates.
✕Probably not a fit
People with Fitzpatrick skin types V–VI, lesions centered on the central face (cheeks and nose), pregnant individuals, or those with epilepsy, fever, active infections, or other exclusion criteria are unlikely to qualify or derive benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-centre experience and efficacy project of the CE‑marked ADVATx laser system conducted at the University of Szeged Dermatology Department. Participants will receive one ADVATx treatment per month for four months, with each session lasting about 10–30 minutes and a total study duration of roughly five months including follow-up. Outcomes include standardized photographic documentation, a patient-reported satisfaction questionnaire, and monitoring for local side effects such as erythema, hyperpigmentation, oedema, pain, blisters or burns. The ADVATx device uses 589 nm and 1319 nm wavelengths and will be operated only by medically qualified laser personnel.
Why it matters
Potential benefit: If successful, the ADVATx laser could produce visible lightening and improved cosmetic appearance of port-wine stains with short outpatient treatments.
How similar studies have gone: Other vascular laser systems (for example pulsed dye and wavelength-combination lasers) have shown benefit for port‑wine stains, but published clinical data specifically on the ADVATx device are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The patient understands the information provided, gives informed consent to participate in the study and is deemed by the investigator to be able to participate, 2. a signed consent form, 3. parental consent is required for patients under 18 years of age, 4. the lesions to be treated are at least 15 cm2, 5. the study is open to Fitzpatrick skin types I-IV. Exclusion Criteria: 1. Lack of parental consent for patients under 18 years of age, 2. symptoms localised to the central part of the face (cheeks, nose), 3. people with Fitzpatrick skin type V-VI, 4. pregnancy, 4\. epilepsy, 5. fever, infectious diseases, 6. the patient is within one month or currently enrolled in another clinical trial.
Where it's running
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University of Szeged, Albert Szent-Györgyi Clinical Centre, Department of Dermatology and Allergology
Szeged, Csongrád-Csanád Vármegye, Hungary Recruiting
Study contacts
- Study coordinator: Lajos Kemény, professor, MD, DSc, MHAS
- Email: kemeny.lajos@med.u-szeged.hu
- Phone: +36305152884
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Comparing pulsed dye, KTP, and sequential KTP→PDL laser treatment for port‑wine stains
This study will try pulsed dye laser, KTP laser, and a sequential KTP then PDL approach on different parts of your port‑wine stain to see which lightens the lesion best and is most tolerable.
-
Maximizing laser therapy success for Port-Wine Birthmarks in kids
This study tests different laser treatment sequences to see which approach clears Port-Wine Stains in children with fewer sessions and less need for anesthesia.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.