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

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Topical Treatment With Clobetasol in Symptomatic Oral Lichen Planus. A Multicenter Placebo-controlled Randomized Clinical Trial.

Conditions
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Oral Lichen Planus

Intervention / Treatment
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* Drug: Clobetasol Propionate
* Drug: Placebo/Klobetasol APL oral gel 0.025%
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active/active<br>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. | Drug: Clobetasol Propionate<br>* Klobetasol APL oral gel 0.025% is a topical steroid for rinsing the oral cavity. Manufactured by APL, Sweden.<br>* Other names: Klobetasol APL oral gel 0.025%;|
| Active Comparator: Placebo/active<br>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. | Drug: Placebo/Klobetasol APL oral gel 0.025%<br>* Placebo/active<br>|
| Placebo Comparator: Placebo/placebo<br>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. | Drug: Placebo<br>* Placebo/placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical appearance of the lichen lesion | Site-, severity- and activity-score according to Escudier et al | Four weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral lichen planus, Treatment, Candida