Evaluating LP-10 in Subjects With OLP

May 12, 2025 updated by: Lipella Pharmaceuticals, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Fremont, California, United States, 94538
        • Center for Dermatology
      • San Francisco, California, United States, 94143
        • UCSF School of Dentistry
    • Florida
      • Miami, Florida, United States, 33176
        • Miami Cancer Institue at Baptist Health, Inc
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • New York
      • Buffalo, New York, United States, 14215
        • Erie County Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Atrium Health Oral Medicine & Maxillofacial Surgery
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19103
        • Paddington Testing Co, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LP-10 0.25mg
0.25mg LP-10 / 10 mL twice daily oral rinse
Drug: LP-10 (Liposomal Tacrolimus)
Liposomal oral rinse formulation of Tacrolimus
Experimental: LP-10 0.5 mg
0.5mg LP-10 / 10 mL twice daily oral rinse
Drug: LP-10 (Liposomal Tacrolimus)
Liposomal oral rinse formulation of Tacrolimus
Experimental: LP-10 1.0 mg
1.0mg LP-10 / 10 mL twice daily oral rinse
Drug: LP-10 (Liposomal Tacrolimus)
Liposomal oral rinse formulation of Tacrolimus

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To evaluate the safety of LP-10 in patients with oral lichen Planus
Time Frame: 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
over 4 weeks of treatment and 2 weeks of follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To evaluate the preliminary efficacy of LP-10 in patients with oral lichen planus
Time Frame: at 4 weeks after first dose
Patient Global Response Assessment (GRA)
at 4 weeks after first dose
To evaluate the preliminary efficacy of LP-10 in patients with oral lichen planus
Time Frame: 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
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
Time Frame: from baseline to 1 and 4 weeks after the first dose and 2 weeks after the last dose
Change in the OLP Reticulation, Erythema, and Ulceration (REU) score
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
Time Frame: from baseline to 1 and 4 weeks after the first dose and 2 weeks after the last dose
Changes in the Oral Lichen Planus Symptom Severity Measure (OLPSSM) score
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
Time Frame: from baseline to 1 and 4 weeks after the first dose and 2 weeks after the last dose
Change in the OLP Pain and Sensitivity Numerical Rating Scale (NRS)
from baseline to 1 and 4 weeks after the first dose and 2 weeks after the last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lipella Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 310-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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