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Evaluating LP-10 in Subjects With OLP

Oral Lichen Planus Clinical Trial

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

Clinical Trial 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 five (5) 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06233591
Study type Interventional
Source Lipella Pharmaceuticals, Inc.
Contact Janet Okonski
Phone 412-894-1853
Email janet.okonski@lipella.com
Status Not yet recruiting
Phase Phase 2
Start date March 1, 2024
Completion date March 1, 2026
View Details
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