Rapamycin Dose-Ranging Efficacy Study in Port Wine Stains

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Port Wine Stains

In brief

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.

Key facts

Study ID: NCT07436611
Run by: AFT Pharmaceuticals, Ltd.
People needed: 30
Starts: 2026-08-01
Expected to finish: 2027-10-01
Last updated by the study team: 2026-07-01

Who can join

Age: any, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
Patients who respond to PDL with purpura or blanching

You may not qualify if…

Skin type classified as either V or VI on the Fitzpatrick scale
Patients with PWS in extremities and/or acral areas
Patients unwilling or unable to carry out the treatment plan or follow-up assessment
Patients with serious skin lesions such as erosions or ulcers
Patients with known hypersensitivity to any component of the study product
Patients who have received rapamycin/sirolimus, everolimus, or temsirolimus within 3 months of enrolment
Patients who have received laser therapy or surgical therapy to treat PWS within 3 months prior to trial enrolment
Patients who have received 5 or more PDL treatments previously
Patients who participated in any other clinical trial within 3 months prior to the day of enrolment
Patients judged unsuitable for this clinical trial by the investigator or sub-investigator
Pregnant or lactating females
Sexually active females of childbearing potential not using adequate contraception and sexually active males not using adequate contraception*
Patients with immune dysfunction or receiving any form of immunosuppression

Where it is running

Driscoll Children's Hospital — Corpus Christi, Texas, United States
Sant Joan de Déu University Hospital — Barcelona, Catalonia, Spain

Full record on ClinicalTrials.gov

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