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

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators want to study the effect of clobetasol in symptomatic oral lichen planus. The investigators will include 90 patients and randomly alocate them in three groups. The frist group will recive active treatment both in the morning an evening. Group two recieves palcebo in the morning and active treatment in the evening. Group three will get palcebo both in the morning and in the evening. All Groups will follow the same protocol with rinsing twice daily with clobetasol in conjunction with antfungal 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 testperiod. Smears for candida will also be evaluated. The patients will be examined for change in clinical apearance and will answer questions to note changes in symptoms. Our hypothesesis: #Patients recieving clobetasolrinses 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 teated 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 clobetasoltreatment compared to those taken before treatment.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Malmö University
• Collaborator: Skane University Hospital
• Treatments: Clobetasol

Criteria

Inclusion Criteria:

• Symptomatic oral lichen planus

• Age above 40 years

Exclusion Criteria:

• Lichenoid contactlesions

• Graft versus host disease

• Bacteriarelated lichenoid reaction

• Intraoral vesiculobulous diseases

• Active antbiotic treatment

• Active treatment with steroids or other immunomodelling substance

• Alergy to Clobetasol

• Severe periodontitis

• Bad oral hygiene

• Biopsy not supporting OLP

• Alergy to nystatin

• Not in menopaus

• Previous or actual oral malignancy

• Participation in other medical study