TOPICAL
8 evidence topics · 1 source
Objective
Objective: comparison of topical sirolimus with vehicle
Location and study date
Protocol publication: planned recruitment start
Study design
Randomized vehicle-controlled design with matched areas within each participant
Eligibility criteria
Treatment
Topical treatment during the blinded comparison period
| Field | Quoted value |
|---|---|
| Sirolimus concentration | “0.1%” |
| Application schedule | “once daily for 12 weeks” |
Study outcomes
Rationale for using physician global assessment as the primary endpoint
Clinical relevance of change on the primary severity scale
Statistical analysis description
Number of participants (Planned and analyzed)
Planned enrollment in the published protocol
| Population | Quoted number |
|---|---|
| Planned participants | “55” |
Description of analysis sets
Summary
The protocol specifies paired Student t tests for the within-participant severity comparison and multiple imputation for missing primary outcomes.
Results
Participant disposition
No evidence found.
Baseline characteristics
No evidence found.
Efficacy results
No evidence found.
Health-related quality of life and patient-reported outcomes
No evidence found.
Safety results
No evidence found.
Study limitations
Summary
The retrieved publication is a protocol rather than a results report. It describes a matched-area, vehicle-controlled comparison during the first 12 weeks, followed by treatment of the whole malformation. The within-person design depends on the comparability of lesion areas and avoidance of treatment contamination between areas. The authors note that systemic absorption could reduce differences between treated and control areas. This 0.1% cream protocol does not establish the efficacy or safety of QTORIN rapamycin 3.9% gel.