LP-10 for Oral Lichen Planus

Not currently recruiting at 6 trial locations

Overseen By Michele Gruber

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Lipella Pharmaceuticals, Inc.

Must not be taking: Antacids, Metoclopramide, Aminoglycosides, others

Disqualifiers: Chronic kidney disease, Cancer, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral rinse treatment called LP-10 (Liposomal Tacrolimus) for individuals with Oral Lichen Planus (OLP), a condition causing painful mouth sores. Researchers aim to assess the safety and effectiveness of different LP-10 doses in alleviating symptoms. Participants will use the rinse twice daily for four weeks, followed by a check-up two weeks later. The trial seeks adults with moderate OLP who can pause their current prescription treatments for the study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

Will I have to stop taking my current medications?

If you are taking prescription oral steroid or rinse treatments, you will need to stop them for the duration of the trial and undergo a 4-week period without them before starting the study. If you are taking certain other medications like magnesium and aluminum-hydroxide antacids, metoclopramide, aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, or protease inhibitors, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that LP-10, a special mouth rinse, is generally safe for people with oral lichen planus. In earlier studies, most participants experienced only mild to moderate side effects. Importantly, very little of the drug entered the bloodstream, reducing the risk of side effects affecting the whole body. This can reassure those considering this treatment. Overall, the safety information suggests that LP-10 is a promising option for managing symptoms with limited risk. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Oral Lichen Planus?

Researchers are excited about LP-10 because it offers a unique approach to treating oral lichen planus, a chronic inflammatory condition. Unlike traditional treatments like topical corticosteroids, LP-10 uses liposomal tacrolimus, which is an innovative delivery method. This liposomal formulation helps the active ingredient, tacrolimus, penetrate more effectively into the affected oral tissues, potentially enhancing its therapeutic effects. Additionally, LP-10 comes in varying dosages (0.25 mg, 0.5 mg, and 1.0 mg), allowing for tailored treatment options based on the severity of the condition. This flexibility and targeted delivery could mean better outcomes for patients, setting LP-10 apart from existing therapies.

What evidence suggests that LP-10 might be an effective treatment for Oral Lichen Planus?

Research has shown that LP-10, a special form of the medication tacrolimus, may help treat Oral Lichen Planus (OLP). This trial will test different doses of LP-10—0.25 mg, 0.5 mg, and 1.0 mg—as separate treatment arms. Studies have found that all tested doses of LP-10 led to noticeable improvements in the sores and redness, common symptoms of OLP. Doctors observed these improvements, and patients reported them. Early results suggest that LP-10 is not only effective but also safe and easy to tolerate, making it a promising option for those dealing with the discomfort of OLP. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Adults over 18 with Oral Lichen Planus (OLP) or oral lichenoid mucositis, without cancer or dysplasia. Participants must have moderate OLP pain and agree to stop any current steroid treatments for the trial's duration. They should be able to follow the study procedures and avoid live vaccines. Women of childbearing potential must test negative for pregnancy and use contraception during the trial.

Inclusion Criteria

I am willing and able to follow all study rules and complete the required questionnaires.

I agree to use reliable birth control during and 10 days after the trial.

I agree to stop my oral steroid treatments for the trial and wait 4 weeks before starting.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 mL LP-10 oral rinse for 3 minutes twice a day

4 weeks

Daily self-administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• LP-10 (Liposomal Tacrolimus)

Trial Overview The safety, tolerability, and effectiveness of LP-10 (Liposomal Tacrolimus) are being tested in different doses (0.25 mg, 0.5 mg, and 1.0 mg). Participants will rinse their mouths with LP-10 twice daily for four weeks followed by a two-week post-treatment evaluation.

How Is the Trial Designed?

Group I: LP-10 1.0 mg Experimental Treatment 1 Intervention

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

Group II: LP-10 0.5 mg Experimental Treatment 1 Intervention

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

Group III: LP-10 0.25mg Experimental Treatment 1 Intervention

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

LP-10 (Liposomal Tacrolimus) is already approved in United States, European Union for the following indications:

Approved in United States as Protopic for:

• Atopic dermatitis
• Moderate to severe atopic dermatitis

Approved in European Union as Protopic for:

• Moderate to severe atopic dermatitis

Who Is Running the Clinical Trial?

Lipella Pharmaceuticals, Inc.

Lead Sponsor

Trials

4

Recruited

70+

Published Research Related to This Trial

In a study of 23 patients with erosive oral lichen planus, 91.3% showed clinical improvement within 6 weeks of treatment with topical tacrolimus, indicating its efficacy.

The treatment was well-tolerated with no evidence of systemic absorption and only minor local side effects, suggesting it is a safe option for managing this painful condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of erosive oral lichen planus with topical tacrolimus. Thomson, MA., Hamburger, J., Stewart, DG., et al.[2013]

Topical tacrolimus therapy has shown significant efficacy in treating severe, recalcitrant erosive oral lichen planus, with rapid pain relief and improvement in lesions observed in two case studies involving patients aged 64 and 68.

Both patients experienced dramatic improvements within 4 to 5 weeks of treatment without significant irritation or adverse effects, suggesting that tacrolimus is a safe and effective alternative for those resistant to traditional corticosteroid therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful treatment of severe recalcitrant erosive oral lichen planus with topical tacrolimus. Shichinohe, R., Shibaki, A., Nishie, W., et al.[2013]

Oral lichen planus is a chronic condition that can cause painful lesions and has the potential to develop into squamous cell carcinoma, highlighting the importance of effective treatment.

A patient showed excellent improvement using a combination of tacrolimus mouthrinse and systemic corticosteroids, suggesting that this treatment approach can be effective for managing the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Oral lichen planus. Insight into the pathogenesis and therapeutic options]. Hilgers, M., Megahed, M.[2021]

Tacrolimus mouth rinse was found to be effective in reducing symptoms of erosive and ulcerative oral lichen planus (OLP), showing significant improvement in REU scores compared to dexamethasone after 4 weeks of treatment.

Although the overall effective rate was similar between tacrolimus and dexamethasone at 4 and 12 weeks, tacrolimus demonstrated quicker effects, suggesting it could be a valuable treatment option for OLP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A randomized single-blind controlled clinical trial of tacrolimus mouth rinse on erosive oral lichen planus]. Zuo, WX., Li, XY., Cai, GY., et al.[2019]

In a study of 6 patients with erosive oral lichen planus who did not respond to topical steroids, treatment with 0.1% topical tacrolimus ointment resulted in substantial improvement.

Topical tacrolimus was well tolerated by the patients, suggesting it is a safe and effective alternative for managing this chronic and painful condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open trial of topical tacrolimus for erosive oral lichen planus. Morrison, L., Kratochvil, FJ., Gorman, A.[2019]

In a study of 19 patients with erosive or ulcerative oral lichen planus, 0.1% topical tacrolimus significantly improved symptoms within just one week, with a mean reduction of 73.3% in ulceration area over 8 weeks.

While tacrolimus was effective, 76% of patients experienced a relapse of symptoms within 2 to 15 weeks after stopping treatment, indicating the need for ongoing management of the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of recalcitrant ulcerative oral lichen planus with topical tacrolimus. Kaliakatsou, F., Hodgson, TA., Lewsey, JD., et al.[2019]

Tacrolimus is an effective immunosuppressive treatment for atopic dermatitis and has shown efficacy in treating oral lichen planus, a mucocutaneous disease.

The review highlights the advantages of tacrolimus over conventional drugs, including its safety profile and effectiveness, making it a popular alternative for managing lichen planus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical tacrolimus in the management of oral lichen planus: literature review. Shilpa, PS., Kaul, R., Bhat, S., et al.[2014]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41174333/

Safety and Efficacy of LP-10 Liposomal Tacrolimus in Oral ... Safety and Efficacy of LP-10 Liposomal Tacrolimus in Oral Lichen Planus: A Multicenter Phase 2 Trial · Abstract · Associated data.

2. link.springer.com link.springer.com/article/10.1007/s13555-025-01572-2

Safety and Efficacy of LP-10 Liposomal Tacrolimus in Oral ... Safety and Efficacy of LP-10 Liposomal Tacrolimus in Oral Lichen Planus: A Multicenter Phase 2 Trial ... Outcome and long-term treatment ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06233591

NCT06233591 | Evaluating LP-10 in Subjects With OLP 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 ...

4. dermatologytimes.com dermatologytimes.com/view/how-lp-10-could-transform-treatment-for-oral-lichen-planus

How LP-10 Could Transform Treatment for Oral Lichen ... Importantly, all doses showed statistically significant improvement in both clinician-assessed endpoints (ulceration and erythema) and patient- ...

5. biospace.com biospace.com/press-releases/lipella-pharmaceuticals-announces-positive-final-results-from-phase-2a-study-of-lp-10-in-oral-lichen-planus

Lipella Pharmaceuticals Announces Positive Final Results ... Lipella Pharmaceuticals Announces Positive Final Results from Phase 2a Study of LP-10 in Oral Lichen Planus · All 27 patients completed treatment ...

6. springermedicine.com springermedicine.com/tacrolimus/lichen-planus/safety-and-efficacy-of-lp-10-liposomal-tacrolimus-in-oral-lichen/51646792

Safety and Efficacy of LP-10 Liposomal Tacrolimus in Oral ... Oral lichen planus (OLP) is a serious chronic inflammatory condition with malignant transformation potential affecting six million Americans ...