Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma
Model scores of the 29,894 trials active now.
Model score 7% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (35 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2017-04-02, after 2016-03-16 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
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2017-04-02. 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
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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: scoretreatment ofto severethe treatmentkidney
Phrases that lowered it: subjectcombinationtopicaloralacid -
Accepts healthy volunteers: No (raises risk) · Who can join
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Minimum age: 21 (lowers risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Has a data monitoring committee: not given (lowers risk) · Design
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Responsible party: principal investigator (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: 18.1% (lowers risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
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Number of arms: 2 (raises risk) · Design
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Blinding: double (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Maximum age: 64 (lowers risk) · Who can join
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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 21 (typical: 18)
- Maximum age
- 64 (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 2 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 2278 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 642 (typical: 412.5)
- Drug's FAERS reports marked serious
- 89.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 18.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- dermatology
- Drugs matched to FDA substances
- hydroquinone, tranexamic acid
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
- Comparison of Azelaic Acid 20 % Cream Versus Hydroquinone 4% Cream as an Adjuvant to Oral Tranexamic Acid in Melasma NCT05887219 · started 2022 · scored riskier than 6% of active trials completed
- Comparison of Efficacy of Tranexamic Acid Mesotherapy Versus 0.9% Normal Saline for Melasma NCT04170088 · started 2018 · scored riskier than 5% of active trials completed
- Efficacy and Safety of a 4% Hydroquinone Cream for the Treatment of Melasma NCT02095990 · started 2014 · scored riskier than 9% of active trials completed
- A Comparative Study for Efficacy and Safety Between 4% Hydroquinone Cream With or Without Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma NCT03049059 · started 2016 · scored riskier than 4% of active trials completed
- Comparison of Intralesional Tranexamic Acid and Platelets Rich Plasma in the Treatment of Melasma NCT05884151 · started 2022 · scored riskier than 5% of active trials completed
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.