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Rapamycin Dose-Ranging Efficacy Study in Port Wine Stains

NCT07436611 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-01

No results posted yet for this 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.

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

Sponsors & Collaborators

  • AFT Pharmaceuticals, Ltd.

    lead INDUSTRY

Principal Investigators

  • Ioana Stanescu · AFT Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-10-31
Completion
2027-10-31
FDA Drug
Yes

Countries

  • United States
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07436611 on ClinicalTrials.gov