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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-HU-25-08-053915 | Other Identifier | National Centre for Public Health and Pharmacy, Budapest |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AdvaTx laser treated | Other | AdvaTx laser treated patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADVATx laser treatment | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 months |
| Pain score during laser treatment measured by Visual Analog Score (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
4. epilepsy, 5. fever, infectious diseases, 6. the patient is within one month or currently enrolled in another clinical trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lajos Kemény, professor, MD, DSc, MHAS | Contact | +36305152884 | kemeny.lajos@med.u-szeged.hu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Szeged, Albert Szent-Györgyi Clinical Centre, Department of Dermatology and Allergology | Recruiting | Szeged | Csongrád-Csanád Vármegye | 6720 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 |
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| ID | Term |
|---|---|
| D019339 | Port-Wine Stain |
| ID | Term |
|---|---|
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012871 | Skin Diseases |
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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). |
| 5 months |
| D017437 | Skin and Connective Tissue Diseases |