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The Efficacy and Molecular Mechanism of Botulinum Toxin in the Reduction of Breast Reduction Mammoplasty Scar Formation

NCT03887377 on ClinicalTrials.gov Phase 2/3 Henry Ford Health System (academic or other) Started 2019-06-10 Completed
Riskier than 13% of active trials
this trial: 9% 0% 36%

Model scores of the 29,894 trials active now.

Model score 9% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 13% of the time (1,012 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2024-12-30, after 2019-06-10 start.

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

0% 23% 47% 70% 93% 0123456 yr completed 81% terminated 12%

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2024-12-30. 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

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
2/3 (typical: 2)
Number of arms
2
Allocation
randomized
Design
single group (typical: parallel)
Primary purpose
prevention (typical: treatment)
Blinding
triple (typical: none)
Has a data monitoring committee
not given (typical: 56% yes)
Responsible party
principal investigator (typical: sponsor)
Collaborators
1 (typical: 0)
Keywords listed
4 (typical: 1)

Who can join

Minimum age
18
Maximum age
65 (typical: 71)
Sex
female (typical: all)
Accepts healthy volunteers
Yes (typical: 9% yes)

Sponsor's track record

Sponsor type
academic or other
Sponsor's past trials
78 (typical: 32)
Sponsor's past termination rate
15.4% (typical: 9.9%)
Trials the sponsor started in the prior 2 years
30 (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
25 (typical: 2148)
Drug's FAERS reports in the prior 12 months
3 (typical: 412.5)
Drug's FAERS reports marked serious
92% (typical: 85.6%)
Drug's FAERS reports with a death
0% (typical: 15.9%)

Disease area and drugs

Disease areas
dermatology
Drugs matched to FDA substances
abobotulinumtoxina

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

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.