Clinical Trial

Efficacy of Topical Treatment With Clobetasol in Symptomatic Oral Lichen Planus.

Active, Not Recruiting Phase 2/3
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Summary
The investigators want to study the effect of clobetasol in symptomatic oral lichen planus. The investigators will include 90 patients and randomly allocate them in three groups. The first group will receive active treatment both in the morning an evening. Group two receives placebo in the morning and active treatment in the evening. Group three will get placebo both in the morning and in the evening. All Groups will follow the same protocol with rinsing twice daily with test substance in conjunction with antifungal treatment. The patients will be controlled after two weeks and and again after another two weeks. A biopsy will be performed at inclusion and another biopsy will be taken at the end of the test period. Smears for candida will also be evaluated. The patients will be examined for changes in clinical appearance and will answer questions to note changes in symptoms. Our hypotheses: #Patients receiving clobetasol will have a better resolution af symptoms than those who got placebo. #Patients treated with clobetasol twice daily will have a faster relief of symptoms than patients just treated once daily. #The clinical signs of oral lichen planus will diminish more pronounced in the two groups given active treatment. #A majority of the OLP lesions were infected by candida. #Specific histological changes can be seen in the biopsies taken after clobetasol treatment compared to those taken before treatment.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2020-04-27; most recent amendment 2024-11-30.
Status change: Recruiting → Active, Not Recruiting 2024-11-30
Status change: Not Yet Recruiting → Recruiting 2020-09-08
Trial Details
NCT Number NCT04364555
Lead Sponsor Malmö University
Collaborators: Skane University Hospital, University of Copenhagen
Conditions Oral Lichen Planus
Enrollment 90 participants
Start Date 2020-05-18
Primary Completion 2024-07-03 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2024-12-04