Ignite Creation Date:
2025-12-18 @ 9:50 AM
Ignite Modification Date:
2025-12-18 @ 9:50 AM
Study NCT ID:
NCT07100613
Status:
None
Last Update Posted:
2025-08-03 00:00:00
First Post:
2025-07-19 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mucoadhesive Modified-Release Formulations for the Topical Treatment of Symptomatic Oral Lichen Planus
Sponsor:
None
Organization:
Study Overview
Official Title:
Efficacy of a Microparticulate Muco-adhesive Patch Containing Drug-nutraceutical Association in paTIents Affected by Oral Mucosa Alterations (EMPATIA)
Status:
None
Status Verified Date:
2025-07
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:
EMPATIA
Brief Summary:
Oral Lichen Planus (OLP) is a chronic inflammatory condition affecting the oral mucosa, often causing painful lesions, burning sensations, and impaired quality of life. Current treatments primarily rely on high-potency topical corticosteroids, such as clobetasol propionate. However, conventional formulations like ointments or pastes may be difficult to apply, poorly retained in the oral cavity, and associated with limited bioavailability or side effects.
This clinical trial investigates the efficacy of a novel mucoadhesive drug delivery system in the form of a patch. The patch is designed to adhere to the oral mucosa, releasing the active compounds in a controlled and prolonged manner. Two types of patches are tested: one containing clobetasol propionate alone and one containing a combination of clobetasol and resveratrol, a natural polyphenol known for its anti-inflammatory and immunomodulatory properties.
The study is a triple-blind, randomized, controlled clinical trial conducted on adult patients with a confirmed histological diagnosis of symptomatic OLP. Participants are randomly assigned to one of three arms:
Arm 1: Patch with clobetasol propionate Arm 2: Patch with clobetasol propionate and resveratrol Arm 3 (Control): Clobetasol 0.05% in an orabase-type adhesive paste Treatments are applied over a 30-day period following a standardized schedule. Clinical evaluations take place at baseline, 15 days, and 30 days, and include photographic documentation, symptom scoring with the Visual Analog Scale (VAS), and clinical severity assessment using the Thongprasom score. In addition, participants complete the Oral Health Impact Profile-14 (OHIP-14) questionnaire to evaluate changes in oral-health-related quality of life.
Structural changes in the mucosa are monitored using Optical Coherence Tomography (OCT), a non-invasive imaging technique that allows real-time visualization of tissue layers, providing objective information on epithelial healing and inflammation.
The primary outcomes are reduction in pain and burning symptoms, improvement of lesion severity, and increased quality of life. Secondary outcomes include patient compliance and OCT-based structural improvement. This study aims to offer a more effective, better tolerated, and innovative therapeutic approach for managing oral lichen planus.
This clinical trial investigates the efficacy of a novel mucoadhesive drug delivery system in the form of a patch. The patch is designed to adhere to the oral mucosa, releasing the active compounds in a controlled and prolonged manner. Two types of patches are tested: one containing clobetasol propionate alone and one containing a combination of clobetasol and resveratrol, a natural polyphenol known for its anti-inflammatory and immunomodulatory properties.
The study is a triple-blind, randomized, controlled clinical trial conducted on adult patients with a confirmed histological diagnosis of symptomatic OLP. Participants are randomly assigned to one of three arms:
Arm 1: Patch with clobetasol propionate Arm 2: Patch with clobetasol propionate and resveratrol Arm 3 (Control): Clobetasol 0.05% in an orabase-type adhesive paste Treatments are applied over a 30-day period following a standardized schedule. Clinical evaluations take place at baseline, 15 days, and 30 days, and include photographic documentation, symptom scoring with the Visual Analog Scale (VAS), and clinical severity assessment using the Thongprasom score. In addition, participants complete the Oral Health Impact Profile-14 (OHIP-14) questionnaire to evaluate changes in oral-health-related quality of life.
Structural changes in the mucosa are monitored using Optical Coherence Tomography (OCT), a non-invasive imaging technique that allows real-time visualization of tissue layers, providing objective information on epithelial healing and inflammation.
The primary outcomes are reduction in pain and burning symptoms, improvement of lesion severity, and increased quality of life. Secondary outcomes include patient compliance and OCT-based structural improvement. This study aims to offer a more effective, better tolerated, and innovative therapeutic approach for managing oral lichen planus.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: