AdvaTx Laser Treatment for Vascular Birthmarks
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-65
SponsorSzeged University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial design
Design model
Single group
Treatments tested in this trial
ADVATx laser treatment
DevicePatients 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: AdvaTx laser treatedOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
5 monthsSecondary outcomes
1
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.
Time frame
5 months2
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).
Time frame
5 monthsSponsors and contacts
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Source ClinicalTrials.gov