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Immunosuppressant

LP-10 for Oral Lichen Planus

Phase 2
Recruiting
Research Sponsored by Lipella Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients of child-bearing potential and male participants with a female partner of child-bearing potential, agree to use a reliable method of contraception (condoms and/or oral contraceptives) for the duration of the trial and for 10 days thereafter
Moderate OLP based on an OLP Investigator Global Assessment (IGA) score of ≥ 3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up an average of 10 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the safety and effectiveness of a drug called LP-10 in treating Oral Lichen Planus (OLP) in adults. About 24 participants will be involved across eight sites in

Who is the study for?
Adults over 18 with Oral Lichen Planus (OLP) or oral lichenoid mucositis, without cancer or dysplasia. Participants must have moderate OLP pain and agree to stop any current steroid treatments for the trial's duration. They should be able to follow the study procedures and avoid live vaccines. Women of childbearing potential must test negative for pregnancy and use contraception during the trial.
What is being tested?
The safety, tolerability, and effectiveness of LP-10 (Liposomal Tacrolimus) are being tested in different doses (0.25 mg, 0.5 mg, and 1.0 mg). Participants will rinse their mouths with LP-10 twice daily for four weeks followed by a two-week post-treatment evaluation.
What are the potential side effects?
While not explicitly listed here, tacrolimus can generally cause side effects such as burning or itching at the application site, increased sensitivity of affected areas, headache, common cold symptoms like sore throat or cough; however specific side effects related to LP-10 would be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use reliable birth control during and 10 days after the trial.
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My oral lichen planus is moderate or severe.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~an average of 10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and an average of 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The primary endpoint of this study is safety assessed by incidence of Treatment-Emergent Adverse Events
Secondary study objectives
Measure the objective effect of LP-10 on OLP by Focused Oral Examination including Intraoral Images
Measure the objective effect of LP-10 on OLP by OLP Investigator Global Assessment (IGA)
Measure the objective effect of LP-10 on OLP by Oral Lichen Planus Symptom Severity Measure (OLPSSM)
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: LP-10 1.0 mgExperimental Treatment1 Intervention
1.0mg LP-10 / 10 mL twice daily oral rinse
Group II: LP-10 0.5 mgExperimental Treatment1 Intervention
0.5mg LP-10 / 10 mL twice daily oral rinse
Group III: LP-10 0.25mgExperimental Treatment1 Intervention
0.25mg LP-10 / 10 mL twice daily oral rinse

Find a Location

Who is running the clinical trial?

Lipella Pharmaceuticals, Inc.Lead Sponsor
3 Previous Clinical Trials
64 Total Patients Enrolled
~15 spots leftby Sep 2025
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