Clinical trial NCT04364555: Efficacy of Topical Treatment With Clobetasol in Symptomatic Oral Lichen Planus.
Official title: Efficacy of Topical Treatment With Clobetasol in Symptomatic Oral Lichen Planus. A Multicenter Placebo-controlled Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Oral Lichen Planus
Keywords: Oral lichen planus
Treatment
Candida
Lead sponsor: Malmö University
Sponsor class: OTHER
Collaborators: name: Skane University Hospital
name: University of Copenhagen
First posted: 2020-04-28
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical appearance of the lichen lesion
timeFrame: Four weeks
Secondary outcomes:
measure: Oral health impact profile
timeFrame: Four weeks
measure: Pain score
timeFrame: Four weeks
measure: Burning sensation score
timeFrame: Four weeks
measure: Histological appearance
timeFrame: Four weeks
measure: Candida
timeFrame: baseline (At treatment start)
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Oral surgery, Universityhospital of Scania
city: Malmö
country: Sweden
facility: Oral Surgery and oral medicine, Malmö University
Study officials:
affiliation: Malmö University
name: Bengt Götrick, Docent
role: STUDY_CHAIR
References: