NCT07436611Not yet recruitingPhase 2
Rapamycin Dose-Ranging Efficacy Study in Port Wine Stains
Rapamycin Dose-Ranging Efficacy Study: A Phase II, Proof of Concept, Double-blind, Placebo-controlled, Randomized, Parallel-group, Dose-response Comparison of the Effects of Different Strengths of Rapamycin Cream Applied Topically in Subjects Diagnosed With Port Wine Stains
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 22 Feb 2026
- Start date
- 13 Nov 2026
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- AFT Pharmaceuticals, Ltd.
- NCT number
- NCT07436611
- EU CT number
- 2025-520821-19-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 13 Nov 2026 to the primary completion date, 31 Oct 2027
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 with immune dysfunction or receiving any form of immunosuppression
Other illness
- Patients with known hypersensitivity to any component of the study product
Other
- 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 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\*
Who the study is looking for
- 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
Age in the registry: - to 10 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sant Joan de Déu University Hospital Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Driscoll Children's Hospital Coordinator of this site? Confirm its status | Corpus Christi | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.