Efficacy of Topical Treatment With Clobetasol in Symptomatic Oral Lichen Planus.

Malmö University

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Oral Lichen Planus

Treatments: Drug: Placebo/Klobetasol APL oral gel 0.025%; Drug: Placebo; Drug: Clobetasol Propionate

Study type: Interventional

Funder types: Other

Identifiers

NCT04364555

LIKLO-1

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

Active/active

Active Comparator group

Description:

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.

Treatment:

Drug: Clobetasol Propionate

Placebo/active

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo/Klobetasol APL oral gel 0.025%

Placebo/placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo