Evaluating LP-10 in Subjects With OLP

NCT06233591 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 310-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 7

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.

Conditions

Oral Lichen Planus

Keywords

OLP

Outcome Measures

Primary Outcomes (1)

• 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

  over 4 weeks of treatment and 2 weeks of follow-up

Secondary Outcomes (5)

• 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

• 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

• 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

• 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

• To evaluate the preliminary efficacy of LP-10 in patients with oral lichen planus

  at 4 weeks after first dose

Study Arms (3)

LP-10 0.25mg

EXPERIMENTAL

0.25mg LP-10 / 10 mL twice daily oral rinse

Drug: LP-10 (Liposomal Tacrolimus)

LP-10 0.5 mg

EXPERIMENTAL

0.5mg LP-10 / 10 mL twice daily oral rinse

Drug: LP-10 (Liposomal Tacrolimus)

LP-10 1.0 mg

EXPERIMENTAL

1.0mg LP-10 / 10 mL twice daily oral rinse

Drug: LP-10 (Liposomal Tacrolimus)

Interventions

LP-10 (Liposomal Tacrolimus) DRUG

Liposomal oral rinse formulation of Tacrolimus

LP-10 0.25mg; LP-10 0.5 mg; LP-10 1.0 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lipella Pharmaceuticals, Inc.: lead

Study Sites (7)

Center for Dermatology

Fremont, California, 94538, United States

Location

UCSF School of Dentistry

San Francisco, California, 94143, United States

Location

Miami Cancer Institue at Baptist Health, Inc

Miami, Florida, 33176, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Erie County Medical Center

Buffalo, New York, 14215, United States

Location

Atrium Health Oral Medicine & Maxillofacial Surgery

Charlotte, North Carolina, 28203, United States

Location

Paddington Testing Co, Inc

Philadelphia, Pennsylvania, 19103, United States

Location

Related Publications (1)

• Brennan MT, Frustino J, Al-Eryani K, Sroussi H, Parish JL, Routh HB, Dhawan S, Klein GL, Chancellor MB, Villa A. Safety and Efficacy of LP-10 Liposomal Tacrolimus in Oral Lichen Planus: A Multicenter Phase 2 Trial. Dermatol Ther (Heidelb). 2025 Oct 31. doi: 10.1007/s13555-025-01572-2. Online ahead of print.

  PMID: 41174333 DERIVED

MeSH Terms

Conditions

Lichen Planus, Oral

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 31, 2024
• Study Start: July 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 15, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)