Oral Lichen Planus
Conditions
Keywords
Oral lichen planus, Treatment, Candida
Brief 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.
Interventions
Klobetasol APL oral gel 0.025% is a topical steroid for rinsing the oral cavity. Manufactured by APL, Sweden.
DRUGPlacebo/Klobetasol APL oral gel 0.025%
Placebo/active
DRUGPlacebo
Placebo/placebo
Sponsors
Skane University Hospital
University of Copenhagen
Malmö University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical appearance of the lichen lesion | Four weeks | Site-, severity- and activity-score according to Escudier et al |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Candida | baseline (At treatment start) | Candida hyphae in smear from lichen lesions |
| Oral health impact profile | Four weeks | Oral health impact profile (OHIP-14) |
| Pain score | Four weeks | VAS scale. A 10 cm scale ranging from no pain what so ever to worst pain imaginable. |
| Burning sensation score | Four weeks | VAS scale. A 10 cm scale ranging from no burning sensation what so ever to worst burning sensation imaginable. |
| Histological appearance | Four weeks | Amount and degree of lichenoid reaction in biopsy |
Countries
Sweden
Outcome results
None listed