Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06233591
Status:
RECRUITING
Last Update Posted:
2024-01-31
First Post:
2023-12-19
Brief Title:
Evaluating LP-10 in Subjects With OLP
Sponsor:
Lipella Pharmaceuticals Inc
Organization:
Lipella Pharmaceuticals Inc
Study Overview
Official Title:
A Multicenter Dose-Ranging Trial Evaluating the Safety Tolerability and Efficacy of LP-10 in Subjects With Symptomatic Oral Lichen Planus
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 025 mg 05 mg and 10 mg of tacrolimusThe 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None