TOPGUN
7 evidence topics · 1 source
Objective
Location and study date
Study design
Randomized timing of treatment introduction
| Field | Quoted value |
|---|---|
| Allocation ratio across four sequences | “1:1:1:1” |
Eligibility criteria
Treatment
Study outcomes
Rationale for using physician global assessment as the primary endpoint
Statistical analysis description
Number of participants (Planned and analyzed)
Sample-size rationale in the protocol
Description of analysis sets
Summary
The planned mixed-effects linear model includes a participant-specific random intercept for repeated severity measurements. Missing observations are not imputed.
Missing-data handling
Results
Participant disposition
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 publication reports a stepped-wedge protocol, not final efficacy or safety results. There is no placebo intervention. Participants and investigators know when treatment starts, although the photographic adjudication committee is blinded. No formal sample-size calculation was performed. The analysis plan models repeated severity measurements, but does not impute missing observations. Local application of a 1 mg/mL oral solution to lingual lesions is not equivalent to cutaneous QTORIN rapamycin 3.9% gel.