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

NCT ID: NCT04364555

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-18

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Oral Lichen Planus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active/active

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.

Group Type ACTIVE_COMPARATOR

Clobetasol Propionate

Intervention Type DRUG

Klobetasol APL oral gel 0.025% is a topical steroid for rinsing the oral cavity. Manufactured by APL, Sweden.

Placebo/active

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.

Group Type ACTIVE_COMPARATOR

Placebo/Klobetasol APL oral gel 0.025%

Intervention Type DRUG

Placebo/active

Placebo/placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo/placebo

Interventions

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Clobetasol Propionate

Klobetasol APL oral gel 0.025% is a topical steroid for rinsing the oral cavity. Manufactured by APL, Sweden.

Intervention Type DRUG

Placebo/Klobetasol APL oral gel 0.025%

Placebo/active

Intervention Type DRUG

Placebo

Placebo/placebo

Intervention Type DRUG

Other Intervention Names

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Klobetasol APL oral gel 0.025%

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Skane University Hospital

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role collaborator

Malmö University

OTHER

Sponsor Role lead

Responsible Party

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Fredrik Gränse

Dentist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bengt Götrick, Docent

Role: STUDY_CHAIR

Malmö University

Locations

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Oral surgery, Universityhospital of Scania

Lund, , Sweden

Site Status

Oral Surgery and oral medicine, Malmö University

Malmo, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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LIKLO-1

Identifier Type: -

Identifier Source: org_study_id