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

StatusActive, Not Recruiting
PhasePhase 2/3
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruitingv5 Show 4 more changesShow less
    • Primary completion date changed from estimate of Jul 2024 to Jul 3, 2024
    • Study completion date: Aug 2024 to Dec 2025
    • Site details revised at 2 of 2 sites
    • Collaborators: 1 to 2
  2. Primary completion date: Jun 2023 to Jul 2024
    • Study completion date: Jul 2023 to Aug 2024
    v4
  3. Primary completion date: Apr 2022 to Jun 2023v3 Show 6 more changesShow less
    • Primary endpoint revised
    • Study completion date: Apr 2022 to Jul 2023
    • Interventions: Clobetasol Propionate (Drug), Placebo/active (Drug), Placebo/placebo (Drug) to Clobetasol Propionate (Drug), Placebo (Drug), Placebo/Klobetasol APL oral gel 0.025% (Drug)
    • Secondary endpoints revised (5)
    • Site contacts updated at 2 of 2 sites
    • Eligibility criteria expanded, about 2 words
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of May 2020 to May 18, 2020
    • Secondary endpoints: details revised at 2 of 5 entries
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04364555
Lead Sponsor Malmö University
Collaborators: Skane University Hospital, University of Copenhagen
Conditions
(from sponsor)		 Oral Lichen Planus
Related terms Lichen Planus, Oral, Torulopsis
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov