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.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511937-37-01

Enrollment

Registered

2026-06-15

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular malfomation

Brief summary

• 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.

Detailed description

• 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.

Interventions

DRUGRapamune 1 mg/mL oral solution

DRUGRapamune 2 mg coated tablets

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
• 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.	—

Secondary

Measure	Time frame
• 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.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 16, 2026