evaluating lp-10 in subjects with olp

Conditions: Oral Lichen Planus

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.


Eligibility criteria:
inclusion criteria: * provide written informed consent * male or female ≥ 18 years of age * oral biopsy performed within the last 10 years before the screening visit demonstrating olp and/or oral lichenoid mucositis in the absence of cancer or dysplasia * 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 the screening visit agree to stop treatment for the duration of the trial and to undergo a 4-week washout period * willing and capable of understanding and complying with all requirements of the protocol, 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 to undergo pregnancy testing at each study visit. (unless patient has undergone a bilateral tubal ligation or hysterectomy and/or is post-menopausal as defined by the absence of menses for at least 12 months) * 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 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 cavity therapeutic or device study within 3 months of screening and has not returned to baseline * history of oral cavity infection (bacterial, viral or fungal) within 3 months prior to 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 per investigator's judgment * patients currently taking magnesium and aluminum-hydroxide antacids or metoclopramide * 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 the opinion of the investigator would make the patient unsuitable for the study

Keywords: olp