Oral Lichen PlanusPhase 2NCT06233591
Evaluating LP-10 in Subjects With OLP
A Phase 2 study testing LP-10 (Liposomal Tacrolimus) in people with Oral Lichen Planus, run by Lipella Pharmaceuticals, Inc. at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- LP-10 (Liposomal Tacrolimus)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Jul 2024to 1 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Erie County Medical Center
Buffalo, New York, 14215
Atrium Health Oral Medicine & Maxillofacial Surgery
Charlotte, North Carolina, 28203
Center for Dermatology
Fremont, California, 94538
Miami Cancer Institue at Baptist Health, Inc
Miami, Florida, 33176
Paddington Testing Co, Inc
Philadelphia, Pennsylvania, 19103
UCSF School of Dentistry
San Francisco, California, 94143
About this study
Official title: 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.
- Conditions
- Oral Lichen Planus
- Being tested
- LP-10 (Liposomal Tacrolimus)
- Keywords
- OLP
- Medical subject headings
- Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LP-10 (Liposomal Tacrolimus)Drug
Liposomal oral rinse formulation of Tacrolimus
| Study group | Role | What they receive |
|---|---|---|
| LP-10 0.25mg | Experimental | 0.25mg LP-10 / 10 mL twice daily oral rinse Receives: Drug: LP-10 (Liposomal Tacrolimus) |
| LP-10 0.5 mg | Experimental | 0.5mg LP-10 / 10 mL twice daily oral rinse Receives: Drug: LP-10 (Liposomal Tacrolimus) |
| LP-10 1.0 mg | Experimental | 1.0mg LP-10 / 10 mL twice daily oral rinse Receives: Drug: LP-10 (Liposomal Tacrolimus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Change in the OLP Investigator Global Assessment (IGA) score
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: at 4 weeks after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Jul 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lipella Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233591
- Sponsor's protocol ID
- 310-001
- Status last verified
- Jul 2024
- First submitted
- 19 Dec 2023
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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). 2026 Jan;16(1):309-321. doi: 10.1007/s13555-025-01572-2. Epub 2025 Oct 31.
PubMed 41174333
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Dose-Ranging Trial Evaluating the Safety, Tolerability, and Efficacy of LP-10 in Subjects With Symptomatic Oral Lichen Planus
- ClinicalTrials.gov ID
- NCT06233591
- Acronym / sponsor ID
- 310-001
- Conditions
- Oral Lichen Planus
- Keywords
- OLP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Lipella Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LP-10 0.25mg | Experimental | Drug: LP-10 (Liposomal Tacrolimus)0.25mg LP-10 / 10 mL twice daily oral rinse |
| LP-10 0.5 mg | Experimental | Drug: LP-10 (Liposomal Tacrolimus)0.5mg LP-10 / 10 mL twice daily oral rinse |
| LP-10 1.0 mg | Experimental | Drug: LP-10 (Liposomal Tacrolimus)1.0mg LP-10 / 10 mL twice daily oral rinse |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (16 listed)
- Hyperkalemia
- Chronic kidney disease
- Long QT syndrome
- History of oral cavity or oropharyngeal cancers
- Active cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LP-10 (Liposomal Tacrolimus)Liposomal oral rinse formulation of Tacrolimus | Drug | LP-10 0.25mg, LP-10 0.5 mg, LP-10 1.0 mg |
Primary outcome
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
5 secondary outcomes
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
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
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
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
To evaluate the preliminary efficacy of LP-10 in patients with oral lichen planus
Time frame: at 4 weeks after first dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Derived from this study: PubMed 41174333Brennan 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). 2026 Jan;16(1):309-321. doi: 10.1007/s13555-025-01572-2. Epub 2025 Oct 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LP-10 (Liposomal Tacrolimus) in people with Oral Lichen Planus, run by Lipella Pharmaceuticals, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06233591, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025; AzTrials last refreshed its copy on 30 Oct 2026.