NCT07250945

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

September 23, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 26, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

December 10, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

September 23, 2025

Last Update Submit

February 5, 2026

Conditions

Port-wine Stains (PWS)Vascular Birthmark

Keywords

ADVATx laserPort-wine stainVascular Birthmark

Outcome Measures

Primary Outcomes (1)

  • Change in lesion presentation measured by Investigator Global Assessment (IGA)

    The IGA is a five-point scale from 0 (no change) to 4 (complete or nearly complete clearance). Three blinded dermatologists will review standardized clinical photographs to evaluate each treated area. Results will be reported as the average IGA score for each treatment method.

    5 months

Secondary Outcomes (2)

  • Patient satisfaction score

    5 months

  • Pain score during laser treatment measured by Visual Analog Score (VAS)

    5 months

Study Arms (1)

AdvaTx laser treated

OTHER

AdvaTx laser treated patients

Device: ADVATx laser treatment

Interventions

ADVATx laser treatmentDEVICE

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.

AdvaTx laser treated

Eligibility Criteria

Age7 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Szeged, Csongrád-Csanád Vármegye, 6720, Hungary

RECRUITING

Related Publications (2)

  • Clinicians Rely on ADVATx for Acne Scars and Unwanted Vascularity By Kevin A. Wilson, Contributing Editor THE Aesthetic Guide May/June 2018 www.aestheticchannel.com

    BACKGROUND

  • Next-Generation ADVATx Platform Transcends Pulsed Dye Lasers By Kevin A. Wilson, Contributing Editor The Aesthetic Guide March/April 2018 www.aestheticchannel.com

    BACKGROUND

MeSH Terms

Conditions

Port-Wine Stain

Condition Hierarchy (Ancestors)

Skin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Lajos Kemény, professor, MD, DSc, MHAS

CONTACT

+36305152884kemeny.lajos@med.u-szeged.hu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD, DSc, MHAS

Study Record Dates

First Submitted

September 23, 2025

First Posted

November 26, 2025

Study Start

December 10, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)