drugset / Trial / NCT07436611

Rapamycin Dose-Ranging Efficacy Study in Port Wine Stains

NCT07436611

Phase 2 Not yet recruiting 30 enrolled AFT Pharmaceuticals, Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The goal of this clinical trial is to learn if the use of rapamycin cream can be used as a treatment together with pulsed dyed laser in treating port wine stain birthmarks. The main question it aims to answer is: Will rapamycin cream and laser treatment show a greater improvement in appearance of port wine birthmarks, compared to treatment with placebo cream and laser? Researchers will compare two concentrations of rapamycin cream (0.6% or 1.0%) with placebo treatment to see if appearance is improved following 12 weeks of treatment. Participants will receive laser treatment of their port wine birthmark and then apply the rapamycin or placebo cream daily for 12 weeks. Patients will visit the clinic every 4 weeks for checkups and tests.

Timeline

Start
2026-08
Primary completion
2027-10
Completion
2027-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Sirolimus Small molecule 0.6 % Topical
Subject Sirolimus Small molecule 1 % Topical