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NCT06158113 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Baricitinib in Oral Lichen Planus: a Proof-of-Concept Study
A Phase 2 study of Oral Lichen Planus and Lichen Planus, Oral, sponsored by University of North Carolina, Chapel Hill.
- Active
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT06158113: Active Phase 2 study of Oral Lichen Planus and Lichen Planus, Oral, sponsored by University of North Carolina, Chapel Hill.
NCT06158113 is a Phase 2 study of Oral Lichen Planus and Lichen Planus, Oral that is active but no longer recruiting, run by University of North Carolina, Chapel Hill. The registered enrollment target is 10 participants, below the 22-participant average among 3 other Oral Lichen Planus trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06158113, a Phase 2 study of Oral Lichen Planus and Lichen Planus, Oral, is active but no longer recruiting, sponsored by University of North Carolina, Chapel Hill.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to learn the effects of baricitinib (the study drug) in patients with Oral Lichen Planus. The main questions it aims to answer are: * What is the efficacy of baricitinib in treating moderate to severe Oral Lichen Planus? * Can baricitinib treatment in Oral Lichen Planus change quality of life? * What side effects do patients with Oral Lichen Planus experience when treated with baricitinib? Participants will be required to come in to monthly visits for up to eight months. During visits, participants will be: * Evaluated for the extent of their disease * Asked to fill out a questionnaire about their quality of life * Given baricitinib for them to take at home for six months * Evaluated for any potential side experienced while on treatment * Asked to return 1 month after completing treatment
Primary Outcome
The Oral Disease Severity Scale (ODSS) is a validated tool to assess severity of Oral Lichen Planus. For scoring, the oral cavity is divided into 17 sites and assigned three different scores. A site score, which captures disease extent, a severity score, and an activity score which is obtained by multiplying the site and severity scores. Independently study participants are asked to fill in a numerical rating scale graded from 0-10, with zero meaning no pain and 10 being the worst imaginable pai
Conditions Studied
Interventions
- DRUG Baricitinib 4 milligram Oral Tablet
Study Locations (1)
North Carolina
- UNC Dermatology and Skin Cancer Center - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2024-03-13 |
| Est. Completion | 2026-09 |
| Phase | Phase 2 |
What the registry record for NCT06158113 still lists
NCT06158113 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 22-participant average among 3 other Oral Lichen Planus trials with a reported enrollment target (55% lower).
The record links to 3 conditions, with Oral Lichen Planus appearing as the primary indexed condition, and to 1 intervention - of which Baricitinib 4 milligram Oral Tablet is the first listed.
NCT06158113 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06158113 about?
NCT06158113 is a clinical study titled "Efficacy and Safety of Baricitinib in Oral Lichen Planus: a Proof-of-Concept Study". The goal of this clinical trial is to learn the effects of baricitinib (the study drug) in patients with Oral Lichen Planus. The main questions it aims to answer are: * What is the efficacy of baricitinib in treating moderate to severe Oral Lichen Planus? * Can baricitinib treatment in Oral Lichen ...
What is the current status of trial NCT06158113?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2024-03-13. Estimated completion is 2026-09.
What conditions does trial NCT06158113 study?
This clinical trial studies the following conditions: Oral Lichen Planus, Lichen Planus, Oral, Lichen Planus, Mucosal.
What interventions are being tested in trial NCT06158113?
The interventions under investigation include: Baricitinib 4 milligram Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT06158113?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06158113 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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