NCT05838170Phase 2Completed

Study of TP-04 in Participants With Papulopustular Rosacea

Study sponsor: Tarsus Pharmaceuticals, Inc. · TARS

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-11-13Actual

Enrollment · participants37Actual

Source updated2023-11-24Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Papulopustular Rosacea

Treatments or interventions studied

Lotilaner Gel, 2.0%DrugAlso known as TP-04

Primary outcomes · main study measures

Read the study measures

measure: The incidence of treatment emergent adverse events from baseline; description: Incidence of local and systemic TEAEs while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel from baseline; timeFrame: Week 1 through Week 12; measure: Changes from baseline in vital signs change in height in cm; description: Changes from baseline in vital signs change in height in cm while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel; timeFrame: Week 1 through Week 12; measure: Changes from baseline in vital signs change in weight in kg; description: Changes from baseline in vital signs change in weight in kg while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel; timeFrame: Week 1 through Week 12; measure: Changes from baseline in vtial signs change in systolic/diastolic blood pressure in mmHg; description: Changes from baseline in vital signs change in systolic/diastolic blood pressure in mmHg while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel; timeFrame: Week 1 through Week 12; measure: Changes from baseline in vital signs change in pulse in beats per minute; description: Changes from baseline in vital signs change in pulse in beats per minute while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel; timeFrame: Week 1 through Week 12; measure: Changes from baseline in vital signs change in respiratory rate in breaths per minute; description: Changes from baseline in vital signs change in respiratory rate in breaths per minute while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel; timeFrame: Week 1 through Week 12; measure: Changes from baseline in vital signs change in temperature in Celsius; description: Changes from baseline in vital signs change in temperature in Celsius while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel; timeFrame: Week 1 through Week 12; measure: Change from baseline in ECGs change in QRS interval in msec; description: Changes from baseline in ECGs change in QRS interval in msec while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel; timeFrame: Week 1 through Week 12; measure: Changes from baseline in ECGs change in mean ventricular rate (beats/min); description: Changes from baseline in ECGs change in mean ventricular rate (beats/min) while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel; timeFrame: Week 1 through Week 12; measure: Changes in baseline in ECGs change in QTC interval in msec; description: Changes from baseline in ECGs change in QTC interval in msec while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel; timeFrame: Week 1 through Week 12; measure: Changes in clinical chemistry laboratory assessments from baseline; description: Changes from baseline clinical chemistry laboratory values while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel; timeFrame: Week 1 through Week 12; measure: Changes in hematology laboratory assessments from baseline; description: Changes from baseline hematology laboratory values while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel; timeFrame: Week 1 through Week 12; measure: Local tolerability assessment ((0=none, 3=severe): dryness, scaling, erythema, burning/stinging; itching); description: Evaluate local tolerability assessment ((0=none, 3=severe): dryness, scaling, erythema, burning/stinging; itching) of Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel; timeFrame: Week 1 through Week 12

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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