AdvaTx Laser Treatment for Vascular Birthmarks
NCT07250945 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-02-06
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.
Conditions
- Port-wine Stains (PWS)
- Vascular Birthmark
Interventions
- DEVICE
-
ADVATx 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.
Sponsors & Collaborators
-
Szeged University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 7 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-10
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- Hungary
Study Locations
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