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Comparison · NCT03285490-7dd92f59

KX2-391 Ointment 1% vs Placebo: Number of Participants With Clinically Significant Safety Observations- Vital Signs

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. KX2-391 Ointment 1% vs Placebo: Number of Participants With Clinically Significant Safety Observations- Vital Signs. Trial comparisons, record NCT03285490-7dd92f59. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03285490-7dd92f59

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 100.000000000000000001730.0211wilson
Risk in group 2000.0217wilson
Risk difference, group 1 minus group 20-0.02170.0211newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to treatfrom the risk difference intervalthe two groups' risks are equal

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1KX2-391 Ointment 1%KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.0178OG001
Group 2PlaceboVehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.0173OG000

Outcome

Type
SECONDARY
Title
Number of Participants With Clinically Significant Safety Observations- Vital Signs
Description
Vital signs included measurement of pulse rate, systolic and diastolic blood pressure, respiratory rate, and body temperature. Clinical significance was determined by the investigator.
Time frame
From Baseline (Day 1 predose) up to Day 57
Population
Safety Population included all randomized participants who received at least one dose of study treatment.

Source ClinicalTrials.gov

Trial

Title
A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004)
NCT number
NCT03285490
Phases
PHASE3
Conditions
Actinic Keratosis
Interventions
KX2-391 Ointment 1%, Placebo
Lead sponsor
Almirall, S.A.
Results first posted
2021-03-10

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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