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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Hungary
University of Szeged, Albert Szent-Györgyi Clinical Centre, Department of Dermatology and Allergology
RECRUITING
Szeged
Contact Information
Primary
Lajos Kemény, professor, MD, DSc, MHAS
kemeny.lajos@med.u-szeged.hu
+36305152884
Time Frame
Start Date: 2025-12-10
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 20
Treatments
Other: AdvaTx laser treated
AdvaTx laser treated patients
Sponsors
Leads: Szeged University

This content was sourced from clinicaltrials.gov