NCT07436611|Not Yet RecruitingPhase 2DMCFDA Drug
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Sponsor study identifier
Secondary identifiers
CTIS
NIH
interventional
30
2 countries
2
Study Start
November 13, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 22, 2026
Actual (reported)February 27, 2026
Actual (reported)November 13, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Clinic Objective improvement rating at week 12
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.
From before laser treatment to the end of treatment after 12 weeks of cream application
Subjective improvement rating (all timepoints)
From before laser treatment to the end of treatment after 12 weeks of cream application
Clinic Objective improvement rating (all timepoints)
From before laser treatment to the end of treatment after 12 weeks of cream application
Photographic Objective improvement rating (all timepoints)
From before laser treatment to the end of treatment after 12 weeks of cream application
Subjective improvement rating change at follow-up
From before laser treatment to follow-up visit (16 weeks)
Subjective improvement rating (post-treatment)
4 weeks between end of treatment and follow-up visit
Clinic Objective improvement rating change at follow-up
From before laser treatment to follow-up visit (16 weeks)
0.6% rapamycin cream applied daily
1.0% rapamycin cream applied daily
Application of rapamycin cream to port wine birthmark
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
SIROLIMUS
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
GEL
View registry recordFormulated product
SIROLIMUS
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
GEL
View registry recordFormulated product
Rapamycin cream
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
SIROLIMUS
Named ingredient: Sirolimus
View registry recordSIROLIMUS
Named ingredient: Sirolimus
View registry recordRapamycin cream
Named ingredient: Rapamycin
View registry recordDriscoll Children's Hospital
Corpus Christi, Texas, 78411, United States
Sant Joan de Déu University Hospital
Barcelona, Catalonia, 08950, Spain
Ioana Stanescu
AFT Pharmaceuticals
First Submitted
February 22, 2026
First Posted
February 27, 2026
Study Start
November 13, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Treatment of Resistant Port-wine Stains With Bosentan and Pulsed Dye Laser: a Pilot Study
Placebo cream applied daily
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-06
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Source: ClinicalTrials.gov.
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