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Topical Agent

Lotilaner Gel, 2.0% (TP-04) for Papulopustular Rosacea

Phase 2
Waitlist Available
Research Sponsored by Tarsus Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1 through week 12
Awards & highlights

Summary

This trial is testing a gel called TP-04 on people with skin conditions. The gel is applied to the skin regularly for several weeks. It works by killing tiny organisms on the skin that may be causing the symptoms.

Eligible Conditions
  • Papulopustular Rosacea

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1 through week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 through week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in ECGs change in QRS interval in msec
Changes from baseline in ECGs change in mean ventricular rate (beats/min)
Changes from baseline in vital signs change in height in cm
+10 more
Secondary study objectives
Clinician Erythema Assessment (CEA) Score (0=clear; 4=severe) - absolute change from baseline
Facial Inflammatory lesion counts - absolute change from baseline
Facial inflammatory lesion counts - percent change from baseline
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Lotilaner Gel, 2.0% (TP-04)Experimental Treatment1 Intervention
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.
Group II: Vehicle-ControlledPlacebo Group1 Intervention
Participants will be randomized to a 2:1 ratio at baseline to apply vehicle control gel on the face BID for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lotilaner Gel, 2.0%
2023
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Tarsus Pharmaceuticals, Inc.Lead Sponsor
9 Previous Clinical Trials
1,238 Total Patients Enrolled
Jose Trevejo, MD, PhDStudy DirectorTarsus Pharmaceuticals, Inc.
2 Previous Clinical Trials
182 Total Patients Enrolled

Media Library

Lotilaner Gel, 2.0% (Topical Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05838170 — Phase 2
Papulopustular Rosacea Research Study Groups: Lotilaner Gel, 2.0% (TP-04), Vehicle-Controlled
Papulopustular Rosacea Clinical Trial 2023: Lotilaner Gel, 2.0% Highlights & Side Effects. Trial Name: NCT05838170 — Phase 2
Lotilaner Gel, 2.0% (Topical Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05838170 — Phase 2
~15 spots leftby Sep 2025
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