Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Lipella Pharmaceuticals, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
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
Clareo Health | Evaluating LP-10 in Subjects With OLP
