NCT05838170

Study of TP-04 in Participants With Papulopustular Rosacea

A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety, Tolerability, and Efficacy of TP-04 in Participants With Papulopustular Rosacea

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Tarsus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

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.

Conditions

• Papulopustular Rosacea

Interventions

Type	Name	Description
DRUG	Lotilaner Gel, 2.0%	Lotilaner Gel, 2.0% (TP-04) is an aqueous gel formulation of lotilaner, a member of the isoxazoline family of compounds and parasiticide that selectively inhibits parasite-specific gamma-aminobutyric acid (GABA)-gated chloride channels (GABA-Cls).
OTHER	Vehicle control gel	Aqueous gel

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-11-13
• Completion: 2023-11-13
• First posted: 2023-05-01
• Last updated: 2023-11-24

Locations

5 sites across 1 country: Canada