A Phase 2/3 interventional study of Clobetasol Propionate and Placebo/Klobetasol APL oral gel 0.025% in Oral Lichen Planus, sponsored by Malmö University. Active, not recruiting at 2 sites in Sweden. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-04.
Sponsored by Malmö University · Phase 2/3, Interventional, and Treatment
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.
Exclusion Criteria:
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
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%
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
Klobetasol APL oral gel 0.025% is a topical steroid for rinsing the oral cavity. Manufactured by APL, Sweden.
Also known as: Klobetasol APL oral gel 0.025%
Placebo/active
Placebo/placebo
Clinical appearance of the lichen lesion
Site-, severity- and activity-score according to Escudier et al
Time frame: Four weeks
Oral health impact profile
Oral health impact profile (OHIP-14)
Time frame: Four weeks
Pain score
VAS scale. A 10 cm scale ranging from no pain what so ever to worst pain imaginable.
Time frame: Four weeks
Burning sensation score
VAS scale. A 10 cm scale ranging from no burning sensation what so ever to worst burning sensation imaginable.
Time frame: Four weeks
Histological appearance
Amount and degree of lichenoid reaction in biopsy
Time frame: Four weeks
Candida
Candida hyphae in smear from lichen lesions
Time frame: baseline (At treatment start)
Plan to share: No — Still undecided since we dont know what data to share and how, yet.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Malmö University