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RecruitingNot ApplicableNCT07250945

AdvaTx Laser Treatment for Vascular Birthmarks

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

Sponsor

Szeged University

Enrollment

20 participants

Start Date

Dec 10, 2025

Study Type

INTERVENTIONAL

Conditions

Port-wine Stains (PWS)Vascular Birthmark

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

Min Age: 7 YearsMax Age: 65 Years

Inclusion Criteria5

  • 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,
  • a signed consent form,
  • parental consent is required for patients under 18 years of age,
  • the lesions to be treated are at least 15 cm2,
  • the study is open to Fitzpatrick skin types I-IV.

Exclusion Criteria5

  • Lack of parental consent for patients under 18 years of age,
  • symptoms localised to the central part of the face (cheeks, nose),
  • people with Fitzpatrick skin type V-VI,
  • pregnancy,
  • \. epilepsy, 5. fever, infectious diseases, 6. the patient is within one month or currently enrolled in another clinical trial.
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Interventions

DEVICEADVATx laser 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.

Locations(1)

University of Szeged, Albert Szent-Györgyi Clinical Centre, Department of Dermatology and Allergology

Szeged, Csongrád-Csanád Vármegye, Hungary

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NCT07250945