A Multicenter, Dose-Ranging Trial Evaluating the Safety, Tolerability, and Efficacy of LP-10 in Subjects With Symptomatic Oral Lichen Planus
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.
• 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