ADVATx laser treatment for port-wine stains (vascular birthmarks)

Study of the Effectiveness of the ADVATx Laser in the Treatment of Port-wine Stains

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 7 Years to 65 Years
• Sex: All
• Sponsor: Szeged University (Academic / other)
• Locations: 1 site (Szeged, Csongrád-Csanád Vármegye)
• Trial ID: NCT07250945 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Szeged, Csongrád-Csanád Vármegye

• 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

Conditions Port-wine Stains; Vascular Birthmark; ADVATx laser; Port-wine stain