Rapamycin Dose-Ranging Efficacy Study in Port Wine Stains (NCT07436611) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Rapamycin Dose-Ranging Efficacy Study in Port Wine Stains
United States, Spain30 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range10 Years
SexALL
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Inclusion criteria
✓. Male and female patients aged ≤ 10 years on the day informed consent is obtained
✓. Patients presenting either facial, neck, or upper trunk port-wine stains
✓. Port wine stain size of at least 5 cm tall x 2.5 cm wide (2x1 inches)
✓. Patients (or their legal representatives) capable of understanding the explanation of the clinical trial, and who give written informed consent for participation
✓. Patients (or their legal representatives) able to maintain patient diaries following the instructions of the investigator or sub-investigator
✓. Patients (or their guardians) are willing and able to follow instructions to only apply cream to part of their port-wine stain
✓. Skin type classified as either I, II, III or IV on the Fitzpatrick scale
✓. Patients who are indicated for PDL treatment and accept this treatment
Exclusion criteria
✕
What they're measuring
1
Clinic Objective improvement rating at week 12
Timeframe: From before laser treatment to the end of treatment after 12 weeks of cream application