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AdvaTx Laser Treatment for Vascular Birthmarks

RecruitingNAAges 7 Years - 65 YearsAllSzeged University
NCT07250945 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • ADVATx laser treatment
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Where

1 site
University of Szeged, Albert Szent-Györgyi Clinical Centre, Department of Dermatology and Allergology
Szeged, Hungary
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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