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

Efficacy of Topical Treatment With Clobetasol in Symptomatic Oral Lichen Planus. A Multicenter Placebo-controlled Randomized Clinical Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Oral Lichen Planus
• Intervention / Treatment: Drug: Clobetasol Propionate; Drug: Placebo/Klobetasol APL oral gel 0.025%; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Fredrik Gränse, DDS; Phone Number: 0046736954499; Email: fredrik.granse@mau.se
• Study Contact Backup: Name: Bengt Götrick, Docent; Phone Number: 0046406658427; Email: bengt.gotrick@mau.se

Study Locations

• Sweden
  • Lund, Sweden, 22242
    • Recruiting
    • Oral surgery, Universityhospital of Scania
    • Contact: Fredrik Gränse, Phd student; Phone Number: 0046406658432; Email: fredrik.granse@mau.se
    • Contact: Cecilia Wexell, Docent; Phone Number: 004646174320; Email: cecilia.wexell@skane.se
  • Malmö, Sweden, 20506
    • Recruiting
    • Oral Surgery and oral medicine, Malmö University
    • Contact: Bengt Götrick, Docent; Phone Number: 0046406658427; Email: bengt.gotrick@mau.se
    • Contact: Fredrik Gränse, Phd student; Phone Number: 0046406658432; Email: fredrik.granse@mau.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Clobetasol Propionate; Klobetasol APL oral gel 0.025% is a topical steroid for rinsing the oral cavity. Manufactured by APL, Sweden.; Other Names: Klobetasol APL oral gel 0.025%
Active Comparator: 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.	Drug: Placebo/Klobetasol APL oral gel 0.025%; Placebo/active
Placebo Comparator: 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.	Drug: Placebo; Placebo/placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical appearance of the lichen lesion	Site-, severity- and activity-score according to Escudier et al	Four weeks

Secondary Outcome Measures

Outcome Measure	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.	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)

Collaborators and Investigators

• Sponsor: Malmö University
• Collaborators: Skane University Hospital
• Investigators: Study Chair: Bengt Götrick, Docent, Malmo university

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2020
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Treatment; Candida; Oral lichen planus
• Additional Relevant MeSH Terms: Skin Diseases; Stomatognathic Diseases; Mouth Diseases; Skin Diseases, Papulosquamous; Lichenoid Eruptions; Lichen Planus, Oral; Lichen Planus; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Clobetasol
• Other Study ID Numbers: LIKLO-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Still undecided since we dont know what data to share and how, yet.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No