NCT07250945 AdvaTx Laser Treatment for Vascular Birthmarks
| NCT ID | NCT07250945 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Szeged University |
| Condition | Port-wine Stains (PWS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-12-10 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-12-10 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07250945 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 65 Years, studying Port-wine Stains (PWS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07250945 currently recruiting?
Yes, NCT07250945 is actively recruiting participants. Contact the research team at kemeny.lajos@med.u-szeged.hu for enrollment information.
Where is the NCT07250945 trial being conducted?
This trial is being conducted at Szeged, Hungary.
Who is sponsoring the NCT07250945 clinical trial?
NCT07250945 is sponsored by Szeged University. The trial plans to enroll 20 participants.