Rapamycin Dose-Ranging Efficacy Study in Port Wine Stains

NCT07436611 · tracked via the Priya Life Science USA tracker

Sponsor

AFT Pharmaceuticals, Ltd

Phase

Phase 2

Started

2026-11-13

Last updated

2026-10-27

Condition(s) studied

Port Wine Stains

Investigational drug(s) / intervention(s)

Rapamycin cream →Pulsed dyed laser

Rapamycin cream: Application of rapamycin cream to port wine birthmark

Pulsed dyed laser: Pulsed dyed laser (PDL) treatment of port wine birthmark

Study 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.

Eligibility

Sex

ALL

Min age

—

Max age

10 Years

Healthy volunteers

Inclusion Criteria: 1. Male and female patients aged ≤ 10 years on the day informed consent is obtained 2. Patients presenting either facial, neck, or upper trunk port-wine stains 3. Port wine stain size of at least 5 cm tall x 2.5 cm wide (2x1 inches) 4. Patients (or their legal representatives) capable of understanding the explanation of the clinical trial, and who give written informed consent for participation 5. Patients (or their legal representatives) able to maintain patient diaries following the instructions of the investigator or sub-investigator 6. Patients (or their guardians) are willing and able to follow instructions to only apply cream to part of their port-wine stain 7. Skin type classified as either I, II, III or IV on the Fitzpatrick scale 8. Patients who are indicated for PDL treatment and accept this treatment 9. Patients who respond to PDL with purpura or blanching Exclusion Criteria: 1. Skin type classified as either V or VI on the Fitzpatrick scale 2. Patients with PWS in extremities and/or acral areas 3. Patients unwilling or unable to carry out the treatment plan or follow-up assessment 4. Patients with serious skin lesions such as erosions or ulcers 5. Patients with known hypersensitivity to any component of the study product 6. Patients who have received rapamycin/sirolimus, everolimus, or temsirolimus within 3 months of enrolment 7. Patients who have received laser therapy or surgical therapy to treat PWS within 3 months prior to trial enrolment 8. Patients who have received 5 or more PDL treatments previously 9. Patients who participated in any other clinical trial within 3 months prior to the day of enrolment 10. Patients judged unsuitable for this clinical trial by the investigator or sub-investigator 11. Pregnant or lactating females 12. Sexually active females of childbearing potential not using adequate contraception and sexually active males not using adequate contraception\* 13. Patients with immune dysfunction or receiving any form of immunosuppression

Primary outcome measure(s)

Clinic Objective improvement rating at week 12 — From before laser treatment to the end of treatment after 12 weeks of cream application
The average percentage improvement (0-100% with higher scores being a better outcome) of port wine stain appearance in the cream treated area from baseline to week 12, or at last visit if early withdrawal/discontinuation occurs, as assessed by the principal investigator during the clinic visit.

Trial sites (2)

Facility	City	Region	Status
Driscoll Children's Hospital	Corpus Christi	Texas
Sant Joan de Déu University Hospital	Barcelona	Catalonia

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07436611 on ClinicalTrials.gov ↗ ← All trials in the USA