A Phase 2 interventional study of LP-10 (Liposomal Tacrolimus) in Oral Lichen Planus, sponsored by Lipella Pharmaceuticals, Inc.. Active, not recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by Lipella Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
Among 13 studies in Lichen Planus, Oral with a site in United States — none open to participants now, 1 under way, none of them phase 3. Lichen Planus, Oral · United States.
Among the 13 studies in Lichen Planus, Oral with a site in United States, this one is the 5th largest by planned enrollment of the 12 interventional ones that give a count, is one of 2 that started in 2024, is one of 10 in phase 2, and was the 12th registered.
142 studies on the registry are indexed under Lichen Planus, Oral; 27 are open to participants now.
Browse Lichen Planus, Oral studies →None of the 13 studies in Lichen Planus, Oral with a site in United States is open now. The open studies under Lichen Planus, Oral, anywhere →
Of the 14 Lichen Planus, Oral studies recruiting now, 10 (71%) set no upper age limit and 2 (14%) stop at 75 or younger; 3 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 11 · Phase 3 1
First in 2003; this study’s year is marked. 2 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 24 is below the median of 39 across 101 interventional studies indexed under Lichen Planus, Oral.
Median enrollment 24 across the 12 interventional studies. Of the 11 that completed or were terminated, 5 (45%) have results posted.
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2 of 13 have an industry lead sponsor. The 10 most frequent:
Lipella Pharmaceuticals, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Lipella Pharmaceuticals, Inc. has 1 study filed under Lichen Planus, Oral — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 13 studies in Lichen Planus, Oral with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
0.25mg LP-10 / 10 mL twice daily oral rinse
Drug: LP-10 (Liposomal Tacrolimus)
0.5mg LP-10 / 10 mL twice daily oral rinse
Drug: LP-10 (Liposomal Tacrolimus)
1.0mg LP-10 / 10 mL twice daily oral rinse
Drug: LP-10 (Liposomal Tacrolimus)
Liposomal oral rinse formulation of Tacrolimus
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
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2024 (actual). Primary completion is estimated for Jun 2025, 11 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tacrolimus
Lipella Pharmaceuticals, Inc.