Clobetasol propionate
DrugKlobetasol APL oral gel 0.025% is a topical steroid for rinsing the oral cavity. Manufactured by APL, Sweden.
Other names: Klobetasol APL oral gel 0.025%
NCT Number: NCT04364555
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.
This study is active but is not currently recruiting participants.
40 year and older
All sexes
Interventional
Phase 2 / Phase 3
Oral surgery, Universityhospital of Scania, Lund, Sweden
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Klobetasol APL oral gel 0.025% is a topical steroid for rinsing the oral cavity. Manufactured by APL, Sweden.
Other names: Klobetasol APL oral gel 0.025%
Placebo/active
Placebo/placebo
Time frame: Four weeks
Site-, severity- and activity-score according to Escudier et al
Time frame: Four weeks
Oral health impact profile (OHIP-14)
Time frame: Four weeks
VAS scale. A 10 cm scale ranging from no pain what so ever to worst pain imaginable.
Time frame: Four weeks
VAS scale. A 10 cm scale ranging from no burning sensation what so ever to worst burning sensation imaginable.
Time frame: Four weeks
Amount and degree of lichenoid reaction in biopsy
Time frame: baseline (At treatment start)
Candida hyphae in smear from lichen lesions
Malmö University
Other
Efficacy of Topical Treatment With Clobetasol in Symptomatic Oral Lichen Planus. A Multicenter Placebo-controlled Randomized Clinical Trial.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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