Clinical trial Recruiting at 1 site Interventional Ages 7 to 65

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 typeInterventional
Ages7 Years to 65 Years
SexAll
Enrollment20 (estimated)
SponsorSzeged University
Academic / other
Locations1 site (Szeged, Csongrád-Csanád Vármegye)
StatusRecruiting
StartedDecember 10, 2025
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedFebruary 6, 2026
Trial IDNCT07250945 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

  • University of Szeged, Albert Szent-Györgyi Clinical Centre, Department of Dermatology and Allergology
    Szeged, Csongrád-Csanád Vármegye, Hungary
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.