Port-wine Stains (PWS), Vascular Birthmark
Conditions
Keywords
ADVATx laser, Port-wine stain, Vascular Birthmark
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
Interventions
DEVICEADVATx 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
Szeged University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in lesion presentation measured by Investigator Global Assessment (IGA) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction score | 5 months | Patients will rate their satisfaction with the treated area using a 0-6 scale, where 0 indicates no satisfaction and 6 indicates very satisfied. |
| Pain score during laser treatment measured by Visual Analog Score (VAS) | 5 months | 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). |
Countries
Hungary
Contacts
CONTACTLajos Kemény, professor, MD, DSc, MHAS
Outcome results
None listed