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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Liposomal oral rinse formulation of Tacrolimus
Center for Dermatology
Fremont, California, United States
UCSF School of Dentistry
San Francisco, California, United States
Miami Cancer Institue at Baptist Health, Inc
Miami, Florida, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
To evaluate the safety of LP-10 in patients with oral lichen Planus
Incidence and severity of treatment-emergent adverse events, changes in standard laboratory studies, whole-blood tacrolimus levels
Time frame: over 4 weeks of treatment and 2 weeks of follow-up
To evaluate the preliminary efficacy of LP-10 in patients with oral lichen planus
Change in the OLP Investigator Global Assessment (IGA) score
Time frame: from baseline to 1 and 4 weeks after the first dose and 2 weeks after the last dose
To evaluate the preliminary efficacy of LP-10 in patients with oral lichen planus
Change in the OLP Reticulation, Erythema, and Ulceration (REU) score
Time frame: from baseline to 1 and 4 weeks after the first dose and 2 weeks after the last dose
To evaluate the preliminary efficacy of LP-10 in patients with oral lichen planus
Changes in the Oral Lichen Planus Symptom Severity Measure (OLPSSM) score
Time frame: from baseline to 1 and 4 weeks after the first dose and 2 weeks after the last dose
To evaluate the preliminary efficacy of LP-10 in patients with oral lichen planus
Change in the OLP Pain and Sensitivity Numerical Rating Scale (NRS)
Time frame: from baseline to 1 and 4 weeks after the first dose and 2 weeks after the last dose
To evaluate the preliminary efficacy of LP-10 in patients with oral lichen planus
Patient Global Response Assessment (GRA)
Time frame: at 4 weeks after first dose
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