Oral Lichen Planus
Conditions
Keywords
OLP
Brief 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.
Interventions
DRUGLP-10 (Liposomal Tacrolimus)
Liposomal oral rinse formulation of Tacrolimus
Sponsors
Lipella Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the safety of LP-10 in patients with oral lichen Planus | over 4 weeks of treatment and 2 weeks of follow-up | Incidence and severity of treatment-emergent adverse events, changes in standard laboratory studies, whole-blood tacrolimus levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the preliminary efficacy of LP-10 in patients with oral lichen planus | from baseline to 1 and 4 weeks after the first dose and 2 weeks after the last dose | Change in the OLP Investigator Global Assessment (IGA) score |
Countries
United States
Outcome results
None listed