LP-10 for Oral Lichen Planus

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Lipella Pharmaceuticals, Inc.

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

Disqualifiers: Chronic kidney disease, Cancer, Hypertension, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug LP-10 (Liposomal Tacrolimus) for treating oral lichen planus?

Research shows that topical tacrolimus, a component of LP-10, is effective in treating erosive oral lichen planus, providing rapid pain relief and significant improvement in symptoms without major side effects. ^{1 2 3 4 5}

Is LP-10 (Liposomal Tacrolimus) safe for humans?

Studies have shown that topical tacrolimus, which is similar to LP-10, is generally safe for treating oral lichen planus, with no significant irritation or harmful effects observed in patients. ^{1 2 4 6 7}

How is the drug LP-10 different from other treatments for oral lichen planus?

LP-10, which is liposomal tacrolimus, is unique because it uses a liposomal delivery system to enhance the effectiveness of tacrolimus, an immunosuppressive drug, for treating oral lichen planus. This approach may offer better absorption and fewer side effects compared to traditional topical treatments. ^{1 2 3 4 7}

Research Team

Eligibility Criteria

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 am 18 years old or older.

Trial Timeline

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)

Treatment Details

Interventions

• LP-10 (Liposomal Tacrolimus) (Immunosuppressant)

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.

Participant Groups

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

Who Is Running the Clinical Trial?

Lipella Pharmaceuticals, Inc.

Lead Sponsor

Trials

4

Recruited

70+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Treatment of erosive oral lichen planus with topical tacrolimus. [2013]

2. England pubmed.ncbi.nlm.nih.gov

Successful treatment of severe recalcitrant erosive oral lichen planus with topical tacrolimus. [2013]

3. Germany pubmed.ncbi.nlm.nih.gov

[Oral lichen planus. Insight into the pathogenesis and therapeutic options]. [2021]

4. China pubmed.ncbi.nlm.nih.gov

[A randomized single-blind controlled clinical trial of tacrolimus mouth rinse on erosive oral lichen planus]. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

An open trial of topical tacrolimus for erosive oral lichen planus. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Management of recalcitrant ulcerative oral lichen planus with topical tacrolimus. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Topical tacrolimus in the management of oral lichen planus: literature review. [2014]