Clinical Assessment of Protopic® Ointment in Deep Partial-Thickness Burns
Model scores of the 29,894 trials active now.
Model score 21% for any early termination, 11% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 11% of the time (918 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2026-04-20, after 2024-09-19 start.
Reason given by the sponsor: “other”
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2026-04-20. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: subjectparticipationinjurydaysprior
Phrases that lowered it: patientsointmentsafety ofefficacyphysical -
Sponsor's past termination rate: 16.0% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 70 (lowers risk) · Sponsor's track record
-
Minimum age: 50 (lowers risk) · Who can join
-
Blinding: single (lowers risk) · Design
-
Drug's FAERS reports with a death: 16.9% (lowers risk) · Drug's FDA history
-
Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports marked serious: 89.2% (raises risk) · Drug's FDA history
-
Drug's FAERS reports before start: 140591 (lowers risk) · Drug's FDA history
-
Primary purpose: treatment (raises risk) · Design
-
Number of arms: 3 (lowers risk) · Design
-
Responsible party: principal investigator (lowers risk) · Design
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Sponsor's past trials: 338 (lowers risk) · Sponsor's track record
-
Disease area, neurology: No (lowers risk) · Disease area
-
Drug's FAERS reports in the prior 12 months: 13661 (lowers risk) · Drug's FDA history
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 1 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- single (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 50 (typical: 18)
- Maximum age
- 75 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 338 (typical: 32)
- Sponsor's past termination rate
- 16.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 70 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 140591 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 13661 (typical: 412.5)
- Drug's FAERS reports marked serious
- 89.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 16.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- tacrolimus
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- StrataGraft® Skin Tissue Expanded Access at Specific Study Sites ( StrataCAT ) NCT04123548 · started 2020 · scored riskier than 48% of active trials completed
- StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects NCT05517902 · started 2023 · scored riskier than 32% of active trials completed
- Safety, Tolerability and Efficacy of Nefopam Cream in Burn Patients NCT04685577 · started 2022 · scored riskier than 41% of active trials completed
- Feasibility Study: Enzymatic Debridement in Patients With Partial Thickness Burns NCT00898521 · started 2009 · scored riskier than 40% of active trials completed
- ST266 Versus Standard Care In Treating Partial Thickness Burns NCT00886470 · started 2009 · scored riskier than 56% of active trials terminated
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.