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Recruiting NCT07250945

AdvaTx Laser Treatment for Vascular Birthmarks

No phase Interventional Port-wine Stains (PWS) Vascular Birthmark

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ADVATx laser treatment.
Who it may be relevant to
Registry conditions: Port-wine Stains (PWS), Vascular Birthmark. Basic parameters: 7 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hungary
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Primary outcome measures

  • Change in lesion presentation measured by Investigator Global Assessment (IGA) [Time frame: 5 months]
Secondary outcome measures (2)
  • Patient satisfaction score [Time frame: 5 months]
  • Pain score during laser treatment measured by Visual Analog Score (VAS) [Time frame: 5 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Hungary · 1 center
  • University of Szeged, Albert Szent-Györgyi Clinical Centre, Department of Dermatology and — Szeged

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

Identifiers

NCT: NCT07250945 · MD-ADVA-01 · CIV-HU-25-08-053915

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗