AdvaTx Laser Treatment for Vascular Birthmarks

NCT ID: NCT07250945

Last Updated: 2026-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-10
• Study Completion Date: 2026-12-31

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.

Detailed Description

Prospective testing and evaluation of a ADVATx, a CE marked device within its intended use, carried out in one centre.

The ADVATx™ laser system, a solid-state laser with wavelengths of 589 nm and 1319 nm. It offers a solution for an exceptionally wide range of indications. It can treat more than 15 indications related to vascular lesions and other dermatological problems with excellent results and high patient safety. It is extremely economical to operate.

Only medical personnel qualified to use medical lasers are authorised to use them.

EUDAMED registration

Advalight card with SRN number:

https://ec.europa.eu/tools/eudamed/#/screen/search-eo/8de1b38d-a0dc-4315-b068-3416928deabe Actor ID/SRN: DK-MF-000010334 Classification of ADVATx: Class IIb medical device

Conditions

Port-wine Stains (PWS); Vascular Birthmark

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AdvaTx laser treated

AdvaTx laser treated patients

Group Type: OTHER

ADVATx laser treatment

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Szeged University

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Kemény Lajos

Professor, MD, DSc, MHAS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Szeged, Csongrád-Csanád Vármegye, Hungary

Site Status: RECRUITING

Countries

Hungary

Central Contacts

Lajos Kemény, professor, MD, DSc, MHAS

Role: CONTACT

kemeny.lajos@med.u-szeged.hu

+36305152884

Facility Contacts

Lajos Kemény, professor, MD, DSc, MHAS

Role: primary

kemeny.lajos@med.u-szeged.hu

+36305152884

References

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

Other Identifiers

CIV-HU-25-08-053915

Identifier Type: OTHER

Identifier Source: secondary_id

MD-ADVA-01

Identifier Type: -

Identifier Source: org_study_id