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

Overview

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.

Full Title of Study: “Efficacy of Topical Treatment With Clobetasol in Symptomatic Oral Lichen Planus. A Multicenter Placebo-controlled Randomized Clinical Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 2024

Interventions

  • Drug: Clobetasol Propionate
    • Klobetasol APL oral gel 0.025% is a topical steroid for rinsing the oral cavity. Manufactured by APL, Sweden.
  • Drug: Placebo/Klobetasol APL oral gel 0.025%
    • Placebo/active
  • Drug: Placebo
    • Placebo/placebo

Arms, Groups and Cohorts

  • Active Comparator: Active/active
    • The one bottle for use in the morning has clobetasol-oral gel, and so does the bottle fore use in the evening. The oral cavity will be rinsed with 5ml oral gel during 1 minute. Nystatin will be taken 1ml 4 times daily.
  • Active Comparator: Placebo/active
    • The bottle for use in the morning contains placebo and one for use in the evening contains clobetasol oral gel. The oral cavity will be rinsed with 5ml oral gel during 1 minute. Nystatin will be taken 1ml 4 times daily.
  • Placebo Comparator: Placebo/placebo
    • Both bottles, the one for the morning and the one for use in the evening, contains placebo. The oral cavity will be rinsed with 5ml oral gel during 1 minute. Nystatin will be taken 1ml 4 times daily.

Clinical Trial Outcome Measures

Primary Measures

  • Clinical appearance of the lichen lesion
    • Time Frame: Four weeks
    • Site-, severity- and activity-score according to Escudier et al

Secondary Measures

  • Oral health impact profile
    • Time Frame: Four weeks
    • Oral health impact profile (OHIP-14)
  • Pain score
    • Time Frame: Four weeks
    • VAS scale. A 10 cm scale ranging from no pain what so ever to worst pain imaginable.
  • Burning sensation score
    • Time Frame: Four weeks
    • VAS scale. A 10 cm scale ranging from no burning sensation what so ever to worst burning sensation imaginable.
  • Histological appearance
    • Time Frame: Four weeks
    • Amount and degree of lichenoid reaction in biopsy
  • Candida
    • Time Frame: baseline (At treatment start)
    • Candida hyphae in smear from lichen lesions

Participating in This Clinical Trial

Inclusion Criteria

  • Symptomatic oral lichen planus – Age above 40 years Exclusion Criteria:

  • Lichenoid contact lesions – Graft versus host disease – Bacteria related lichenoid reaction – Intraoral vesiculobullous diseases – Active antibiotic treatment – Active treatment with steroids or other immunomodulating substance – Allergy to Clobetasol – Severe periodontitis – Bad oral hygiene – Biopsy not supporting OLP – Allergy to nystatin – Not in menopause – Previous or actual oral malignancy – Participation in other medical study

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Malmö University
  • Collaborator
    • Skane University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Fredrik Gränse, Dentist – Malmö University
  • Overall Official(s)
    • Bengt Götrick, Docent, Study Chair, Malmö University
  • Overall Contact(s)
    • Fredrik Gränse, DDS, 0046736954499, fredrik.granse@mau.se

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