Rapamycin Dose-Ranging Efficacy Study in Port Wine Stains
ConditionPort Wine Stains
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 10
SponsorAFT Pharmaceuticals, Ltd.
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Rapamycin cream
- Pulsed dyed laser
Treatment groups
30 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov