A single arm single center exploratory observational phase II study, aimed to detect long term changes in volume of port-wine macrocheilia and color of port-wine stain in patients undergoing surgery and laser therapy during sirolimus treatment. Quality of life and efficacy and safety of sirolimus will be assessed.

Condition studied

Vascular malfomation

Investigational medicinal product(s)

Eligibility

Primary endpoint

• The primary endpoint is relative change in volume of PWM from baseline to 60 months. Volume will be evaluated in 3 dimensions with at caliper.

Endpoint detail

• The main secondary endpoint is change in color intensity of PWS from baseline to 60 months. Color will be evaluated four categories light red/pink, deep red, bluish red and purple., • The additional secondary endpoint is change of quality of life from baseline to 60 months. Quality of life will be evaluated by OVAMA face and neck score.