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NOT YET RECRUITING

NCT07436611

PHASE2

Rapamycin Dose-Ranging Efficacy Study in Port Wine Stains

Sponsor: AFT Pharmaceuticals, Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

Any - 10 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04

Completion Date

2027-10

Last Updated

2026-02-27

Healthy Volunteers

Conditions

Port Wine Stains

Interventions

DRUG

Rapamycin cream

Application of rapamycin cream to port wine birthmark

PROCEDURE

Pulsed dyed laser

Pulsed dyed laser (PDL) treatment of port wine birthmark

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

Locations (2)

Driscoll Children's Hospital

Corpus Christi, Texas, United States

Sant Joan de Déu University Hospital

Barcelona, Catalonia, Spain