Evaluating LP-10 in Subjects With OLP

Inclusion Criteria:

• Provide written informed consent

• Male or female ≥ 18 years of age

• Oral biopsy performed within the last 10 years before the Screening Visitdemonstrating OLP and/or oral lichenoid mucositis in the absence of cancer ordysplasia

• Moderate OLP based on an OLP Investigator Global Assessment (IGA) score of ≥ 3

• OLP Pain and Sensitivity Numerical Rating Scale (NRS) score of ≥ 3

• Patients taking prescription oral steroid or rinse treatment(s) at the time of theScreening Visit agree to stop treatment for the duration of the trial and to undergoa 4-week washout period

• Willing and capable of understanding and complying with all requirements of theprotocol, including proper completion of the self-administered questionnaires

• Willing to avoid live vaccines while enrolled in the trial

• Patients of child-bearing potential must have a negative pregnancy test and agree toundergo pregnancy testing at each study visit. (unless patient has undergone abilateral tubal ligation or hysterectomy and/or is post-menopausal as defined by theabsence of menses for at least 12 months)

• Patients of child-bearing potential and male participants with a female partner ofchild-bearing potential, agree to use a reliable method of contraception (condomsand/or oral contraceptives) for the duration of the trial and for 10 days thereafter

Exclusion Criteria:

• Hyperkalemia

• Chronic kidney disease

• Long QT syndrome

• History of oral cavity or oropharyngeal cancers

• Active cancer

• Uncontrolled hypertension (i.e., > 145 mm/Hg systolic or > 95 mmHg diastolic)

• Patients who failed tacrolimus treatment for OLP in the past

• Patient who is currently or has previously participated in another oral cavitytherapeutic or device study within 3 months of screening and has not returned tobaseline

• History of oral cavity infection (bacterial, viral or fungal) within 3 months priorto screening

• Pregnant or lactating

• Active bleeding peptic ulcer disease

• Known allergy to liposomes and/or egg yolk and/or tacrolimus

• Evidence of renal impairment (creatinine > 2 × the upper limit of normal at Visit 1), hepatic impairment (AST or ALT > 3 × the upper limit of normal at Visit 1),clinically significant cardiovascular, respiratory, or psychiatric diseases perinvestigator's judgment

• Patients currently taking magnesium and aluminum-hydroxide antacids ormetoclopramide

• Patients currently taking aminoglycosides, ganciclovir, amphotericin B, cisplatin,nucleotide reverse transcriptase inhibitors, and protease inhibitors

• The presence of any clinically significant systemic disease or condition that in theopinion of the investigator would make the patient unsuitable for the study