NCT06233591

Evaluating LP-10 in Subjects With OLP

A Multicenter, Dose-Ranging Trial Evaluating the Safety, Tolerability, and Efficacy of LP-10 in Subjects With Symptomatic Oral Lichen Planus

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Lipella Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, dose-ranging study including adult male and female subjects (\>= 18 years old) with symptomatic Oral Lichen Planus (OLP). A total of approximately 24 subjects will be enrolled at approximately eight (8) study sites in the United States. This study will evaluate the safety, tolerability and efficacy of LP-10 at 0.25 mg, 0.5 mg and 1.0 mg of tacrolimus.The study consists of screening, treatment and follow-up phases. The treatment phase includes 10 mL LP-10 oral rinse for 3 minutes twice a day for 4 weeks. The follow-up phase includes one post-treatment visit 2 weeks after the last oral LP-10 dose.

Conditions

• Oral Lichen Planus

Interventions

Type	Name	Description
DRUG	LP-10 (Liposomal Tacrolimus)	Liposomal oral rinse formulation of Tacrolimus

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2024-01-31
• Last updated: 2025-05-15

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study