Treatment of Port Wine Stains Using Pulsed Dye Laser, Erbium Yag Laser and Topical Sirolimus

Treatment of Port Wine Stains Using Pulsed Dye Laser, Erbium Yag Laser and Topical Sirolimus in an Open Label Pilot Study (POLAR).

The purpose of this study is to improve the therapeutic outcome of laser therapy for port wine stains by using a combination treatment of the pulsed dye laser (PDL), erbium yag laser and topical sirolimus.

In the first treatment period all patients will receive a total of five treatments with two week intervals. Every patient will receive the following four treatments (utilizing a template with separate squares of 1cm2): 1) PDL treatment followed by topical sirolimus application after Er:Yag laser ablation of the stratum corneum compared with 2) PDL treatment followed by topical sirolimus application without Er:Yag laser ablation of the stratum corneum, 3) PDL treatment only and 4) sirolimus application only. After the six months follow-up period, during the second treatment period, patients will receive an additional five treatments of the adjacent cosmetic unit of the treated part of the PWS, employing the most successful of the four treatment modalities as evaluated after the first treatment period.

Inclusion Criteria:

• Subject has provided informed consent;
• Subject is ≥ 18 years of age at time of screening;
• Subject has an extra-facial homogenous Port Wine Stain (PWS);
• The PWS is large enough in size to fit one of the templates
• Subject has not received any laser treatment of the PWS in the last 3 months (in the treatment area);
• The PWS has a minimal erythema grading score of 3 (on a 4 point scale) in the opinion of the investigator;
• Screening blood safety values are within normal parameters or regarded as not clinically significant in the opinion of the investigator.

Exclusion Criteria:

• PWS with a nodular/hypertrophic component in the treatment area;
• PWS on cosmetically unacceptable locations in the opinion of the investigator;
• For women: pregnant or breast feeding during the treatment period;
• Women of child-bearing potential, unless they are using adequate contraceptive measures
• Subject is known to have immune deficiency, or is immune compromised
• Known allergy to sirolimus or other constituents of the study medication;
• Incapacitated subjects;
• Any medical or psychiatric condition which, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.