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

NCT04364555 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: LIKLO-1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Oral Lichen Planus

Keywords

Oral lichen planus; Treatment; Candida

Outcome Measures

Primary Outcomes (1)

• Clinical appearance of the lichen lesion

  Site-, severity- and activity-score according to Escudier et al

  Four weeks

Secondary Outcomes (5)

• Oral health impact profile

  Four weeks

• Pain score

  Four weeks

• Burning sensation score

  Four weeks

• Histological appearance

  Four weeks

• Candida

  baseline (At treatment start)

Study Arms (3)

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.

Drug: Clobetasol Propionate

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.

Drug: Placebo/Klobetasol APL oral gel 0.025%

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.

Drug: Placebo

Interventions

Clobetasol Propionate DRUG

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%

Active/active

Placebo/Klobetasol APL oral gel 0.025% DRUG

Placebo/active

Placebo/active

Placebo DRUG

Placebo/placebo

Placebo/placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic oral lichen planus
• Age above 40 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Malmö University: lead
• Skane University Hospital: collaborator
• University of Copenhagen: collaborator

Study Sites (2)

Oral surgery, Universityhospital of Scania

Lund, 22242, Sweden

Location

Oral Surgery and oral medicine, Malmö University

Malmo, 20506, Sweden

Location

MeSH Terms

Conditions

Lichen Planus, Oral; Torulopsis

Interventions

Clobetasol

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Bengt Götrick, Docent

  Malmö University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 28, 2020
• Study Start: May 18, 2020
• Primary Completion: July 3, 2024
• Study Completion: December 1, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)