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NCT06233591 · ClinicalTrials.gov registry record · Phase 2
Evaluating LP-10 in Subjects With OLP
A Phase 2 study of Oral Lichen Planus, sponsored by Lipella Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 7
- Study locations
NCT06233591 is a Phase 2 study of Oral Lichen Planus that is active but no longer recruiting, run by Lipella Pharmaceuticals. The registered enrollment target is 24 participants, above the 18-participant average among 3 other Oral Lichen Planus trials with a reported enrollment target (33% higher). The trial reports 7 study locations across 6 states.
The verdict
NCT06233591, a Phase 2 study of Oral Lichen Planus, is active but no longer recruiting, sponsored by Lipella Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 7
- Study locations
Study 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 Studied
Interventions
- DRUG LP-10 (Liposomal Tacrolimus)
Study Locations (7)
California
- Center for Dermatology - Fremont
- UCSF School of Dentistry - San Francisco
Florida
- Miami Cancer Institue at Baptist Health, Inc - Miami
Massachusetts
- Brigham and Women's Hospital - Boston
New York
- Erie County Medical Center - Buffalo
North Carolina
- Atrium Health Oral Medicine & Maxillofacial Surgery - Charlotte
Pennsylvania
- Paddington Testing Co, Inc - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2024-07-01 |
| Est. Completion | 2025-06-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06233591
The ClinicalTrials.gov registry entry for NCT06233591 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 18-participant average among 3 other Oral Lichen Planus trials with a reported enrollment target (33% higher). The listed sponsor is Lipella Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Oral Lichen Planus appearing as the primary indexed condition, and to 1 intervention - of which LP-10 (Liposomal Tacrolimus) is the first listed.
NCT06233591 reports 7 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06233591 about?
NCT06233591 is a clinical study titled "Evaluating LP-10 in Subjects With OLP". 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, tol...
What is the current status of trial NCT06233591?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2024-07-01. Estimated completion is 2025-06-01.
What conditions does trial NCT06233591 study?
This clinical trial studies the following conditions: Oral Lichen Planus.
What interventions are being tested in trial NCT06233591?
The interventions under investigation include: LP-10 (Liposomal Tacrolimus) (DRUG).
Who is sponsoring clinical trial NCT06233591?
This trial is sponsored by Lipella Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06233591 being conducted?
This trial has 7 study locations across California, Florida, Massachusetts, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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