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

• Status: Terminated
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Erasmus Medical Center
• Treatments: Everolimus; Sirolimus

Criteria

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.