Study of TP-04 in Participants With Papulopustular Rosacea
- Conditions
- Papulopustular Rosacea
- Interventions
- Other: Vehicle control gel
- Registration Number
- NCT05838170
- Lead Sponsor
- Tarsus Pharmaceuticals, Inc.
- Brief Summary
This study is being done to evaluate the safety, tolerability, and efficacy of the study drug, TP-04, in participants with papulopustular rosacea (PPR).
- Detailed Description
This is a Phase 2, multicenter, randomized, double-blind, parallel-group, vehicle-controlled study evaluating the safety, tolerability, and efficacy of Lotilaner Gel, 2.0% (TP-04) applied BID for 12 weeks in participants with moderate to severe PPR.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle-Controlled Vehicle control gel Participants will be randomized to a 2:1 ratio at baseline to apply vehicle control gel on the face BID for 12 weeks. Lotilaner Gel, 2.0% (TP-04) Lotilaner Gel, 2.0% Participants will be randomized to a 2:1 ratio at baseline to apply Lotilaner Gel, 2.0% (TP-04) on the face BID for 12 weeks.
- Primary Outcome Measures
Name Time Method The incidence of treatment emergent adverse events from baseline Week 1 through Week 12 Incidence of local and systemic TEAEs while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel from baseline
Changes from baseline in vital signs change in pulse in beats per minute Week 1 through Week 12 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
Changes in hematology laboratory assessments from baseline Week 1 through Week 12 Changes from baseline hematology laboratory values while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes from baseline in vital signs change in height in cm Week 1 through Week 12 Changes from baseline in vital signs change in height in cm while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes from baseline in vital signs change in weight in kg Week 1 through Week 12 Changes from baseline in vital signs change in weight in kg while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes from baseline in vtial signs change in systolic/diastolic blood pressure in mmHg Week 1 through Week 12 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
Changes from baseline in vital signs change in temperature in Celsius Week 1 through Week 12 Changes from baseline in vital signs change in temperature in Celsius while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes from baseline in ECGs change in mean ventricular rate (beats/min) Week 1 through Week 12 Changes from baseline in ECGs change in mean ventricular rate (beats/min) while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Local tolerability assessment ((0=none, 3=severe): dryness, scaling, erythema, burning/stinging; itching) Week 1 through Week 12 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
Changes from baseline in vital signs change in respiratory rate in breaths per minute Week 1 through Week 12 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
Changes in clinical chemistry laboratory assessments from baseline Week 1 through Week 12 Changes from baseline clinical chemistry laboratory values while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Change from baseline in ECGs change in QRS interval in msec Week 1 through Week 12 Changes from baseline in ECGs change in QRS interval in msec while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes in baseline in ECGs change in QTC interval in msec Week 1 through Week 12 Changes from baseline in ECGs change in QTC interval in msec while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
- Secondary Outcome Measures
Name Time Method Facial inflammatory lesion counts - percent change from baseline Week 1 through Week 12 Percent change from baseline in facial inflammatory lesion counts
Improvement in Worst Pruritus Numeric Rating Scale (NRS) Score (0=no itch; 10= worst imaginable itch) Week 1 through Week 12 Proportion (%) of participants achieving at least a 4-point reduction in worst pruritus NRS score (0= no itch; 10= worst imaginable itch)
Improvement in Investigator Global Assessment (IGA) score (0=clear; 4=severe) Week 1 through Week 12 Proportion (%) of participants achieving ≥ 2-point improvement in IGA score to clear (0) or almost clear (1)
Facial Inflammatory lesion counts - absolute change from baseline Week 1 through Week 12 Absolute change from baseline in facial inflammatory lesion counts
Investigator Global Assessmen (IGA) Score (0=clear; 4=severe) - absolute change from baseline Week 1 through Week 12 Absolute change from baseline in IGA score
Clinician Erythema Assessment (CEA) Score (0=clear; 4=severe) - absolute change from baseline Week 1 through Week 12 Absolute change from baseline in CEA score
Pruritus Numeric Rating Scale (NRS) Score (0=no itch; 10= worst imaginable itch) - absolute change from baseline Week 1 through Week 12 Absolute change from baseline in worst pruritus NRS score
Worst Pain Numeric Rating Scale (NRS) Score (0=no pain; 10= worst imaginable pain) - absolute change from baseline Week 1 through Week 12 Absolute change from baseline in worst pain NRS score
Trial Locations
- Locations (5)
The Centre for Clinical Trials
🇨🇦Oakville, Ontario, Canada
Innovaderm Research Inc.
🇨🇦Montréal, Quebec, Canada
SKiN Centre for Dermatology
🇨🇦Peterborough, Ontario, Canada
K. Papp Clinical Research
🇨🇦Waterloo, Ontario, Canada
Centre de Recherche Saint-Louis
🇨🇦Québec, Canada