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| Name | Class |
|---|---|
| Skane University Hospital | OTHER |
| University of Copenhagen | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active/active | Active Comparator | 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. |
|
| Placebo/active | Active Comparator | 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. |
|
| Placebo/placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clobetasol Propionate | Drug | Klobetasol APL oral gel 0.025% is a topical steroid for rinsing the oral cavity. Manufactured by APL, Sweden. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical appearance of the lichen lesion | Site-, severity- and activity-score according to Escudier et al | Four weeks |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bengt Götrick, Docent | Malmö University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oral surgery, Universityhospital of Scania | Lund | 22242 | Sweden | |||
| Oral Surgery and oral medicine, Malmö University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42163196 | Derived | Granse F, Kroona L, Truedsson A, Larsson Wexell C, Gotrick B. Topical clobetasol propionate 0.025% oral gel in the treatment of oral lichen planus: a double-blind, randomized placebo-controlled trial. BMC Oral Health. 2026 May 20;26(1):910. doi: 10.1186/s12903-026-08599-7. |
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Still undecided since we dont know what data to share and how, yet.
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| ID | Term |
|---|---|
| D017676 | Lichen Planus, Oral |
| C536972 | Torulopsis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D008010 | Lichen Planus |
| D017512 | Lichenoid Eruptions |
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| ID | Term |
|---|---|
| D002990 | Clobetasol |
| ID | Term |
|---|---|
| D001623 | Betamethasone |
| D013259 | Steroids, Fluorinated |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo/Klobetasol APL oral gel 0.025% | Drug | Placebo/active |
|
| Placebo | Drug | Placebo/placebo |
|
| 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) |
| Malmö |
| 20506 |
| Sweden |
| D017444 |
| Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011083 |
| Polycyclic Compounds |