Rapamycin Dose-Ranging Efficacy Study in Port Wine Stains

Part of paid clinical trials in Corpus Christi, Texas.

Sponsor
AFT Pharmaceuticals, Ltd.
Study ID
NCT07436611
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Port Wine Stains

Eligibility Criteria

Sex
ALL
Age
N/A - 10 Years
Healthy Volunteers
Not accepted

Interventions

  • Rapamycin cream — DRUG
    Application of rapamycin cream to port wine birthmark
  • Pulsed dyed laser — PROCEDURE
    Pulsed dyed laser (PDL) treatment of port wine birthmark

Study Details

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 Dates

Start date
Apr 30, 2026
Status verified
Feb 2026
Primary completion
Sep 30, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 0.6% rapamycin
    0.6% rapamycin cream applied daily
  • Experimental: 1.0% rapamycin cream
    1.0% rapamycin cream applied daily
  • Placebo Comparator: Placebo cream
    Placebo cream applied daily

Primary Outcome Measure

Clinic Objective improvement rating at week 12 [ Time Frame: From before laser treatment to the end of treatment after 12 weeks of cream application ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Driscoll Children's HospitalCorpus ChristiTexas78411
Erin Richmond, MS, RN, CCRP
[email protected]
361-694-5978
Denise Metry, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Driscoll Children's Hospital· Corpus Christi, TX

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