Evaluating LP-10 in Subjects With OLP

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.

Timeline

Start

2024-07-01

Primary completion

2025-06-01

Completion

2025-06-01

Publications

• Brennan MT, Frustino J, Al-Eryani K, Sroussi H, Parish JL, Routh HB, Dhawan S, Klein GL, Chancellor MB, Villa A. Safety and Efficacy of LP-10 Liposomal Tacrolimus in Oral Lichen Planus: A Multicenter Phase 2 Trial. Dermatol Ther (Heidelb). 2026 Jan;16(1):309-321. doi: 10.1007/s13555-025-01572-2. Epub 2025 Oct 31.

Drugs

Indications