Port-wine Stains (PWS)ADVA-PWSNCT07250945
AdvaTx Laser Treatment for Vascular Birthmarks
A study testing ADVATx laser treatment in people with Port-wine Stains (PWS) and Vascular Birthmark, run by Szeged University at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 65 years
- Conditions the study is for
- Port-wine Stains (PWS), Vascular Birthmark
- What is being tested?
- ADVATx laser treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHungary
- Study dates
- 10 Dec 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
- 4. epilepsy, 5. fever, infectious diseases, 6. the patient is within one month or currently enrolled in another clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site, 1 recruiting
- Recruiting
University of Szeged, Albert Szent-Györgyi Clinical Centre, Department of Dermatology and Allergology
Szeged, Csongrád-Csanád Vármegye, 6720
Lajos Kemény, professor, MD, DSc, MHAS, +36305152884, kemeny.lajos@med.u-szeged.hu
Lajos Kemény, Professor, MD, DSc, MHAS
About this study
Official title: Study of the Effectiveness of the ADVATx Laser in the Treatment of Port-wine Stains
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.
Read more
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.
Read the 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
- Being tested
- ADVATx laser treatment
- Keywords
- ADVATx laser, Port-wine stain, Vascular Birthmark
- Medical subject headings
- Port-Wine Stain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| AdvaTx laser treated | Other | AdvaTx laser treated patients Receives: Device: ADVATx laser treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Secondary outcomes (2)
Patient satisfaction score
Patients will rate their satisfaction with the treated area using a 0-6 scale, where 0 indicates no satisfaction and 6 indicates very satisfied.
Measured: 5 months
Pain score during laser treatment measured by Visual Analog Score (VAS)
Participants will assess their pain during each treatment using a Visual Analog Scale (VAS), which ranges from 0 (no pain) to 10 (the worst imaginable pain).
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start10 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Port-wine Stains (PWS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Kemény Lajos, Szeged University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250945
- Sponsor's protocol ID
- MD-ADVA-01
- Other IDs
- CIV-HU-25-08-053915
- Acronym
- ADVA-PWS
- Status last verified
- Feb 2026
- First submitted
- 23 Sep 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
Next-Generation ADVATx Platform Transcends Pulsed Dye Lasers By Kevin A. Wilson, Contributing Editor The Aesthetic Guide March/April 2018 www.aestheticchannel.com
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effectiveness of the ADVATx Laser in the Treatment of Port-wine Stains
- ClinicalTrials.gov ID
- NCT07250945
- Acronym / sponsor ID
- ADVA-PWS / MD-ADVA-01
- Conditions
- Port-wine Stains (PWS), Vascular Birthmark
- Keywords
- ADVATx laser, Port-wine stain, Vascular Birthmark
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AdvaTx laser treated | Other | Device: ADVATx laser treatmentAdvaTx laser treated patients |
Who may qualify
- Ages
- 7 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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,
- 4. epilepsy, 5. fever, infectious diseases, 6. the patient is within one month or currently enrolled in another clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADVATx laser treatmentPatients 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. | Device | AdvaTx laser treated |
Primary outcome
Change in lesion presentation measured by Investigator Global Assessment (IGA)
Time frame: 5 months
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.
2 secondary outcomes
Patient satisfaction score
Time frame: 5 months
Pain score during laser treatment measured by Visual Analog Score (VAS)
Time frame: 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- BackgroundClinicians Rely on ADVATx for Acne Scars and Unwanted Vascularity By Kevin A. Wilson, Contributing Editor THE Aesthetic Guide May/June 2018 www.aestheticchannel.com
- BackgroundNext-Generation ADVATx Platform Transcends Pulsed Dye Lasers By Kevin A. Wilson, Contributing Editor The Aesthetic Guide March/April 2018 www.aestheticchannel.com
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADVATx laser treatment in people with Port-wine Stains (PWS) and Vascular Birthmark, run by Szeged University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lajos Kemény, professor, MD, DSc, MHAS (+36305152884, kemeny.lajos@med.u-szeged.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lesion presentation measured by Investigator Global Assessment (IGA) (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07250945, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.